Sarcoma trials

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The trial tests whether regorafenib given as maintenance therapy after first-line treatment helps keep bone sarcoma from coming back. Participants are patients 12 years and older with confirmed primary bone sarcoma who have completed standard treatment and have no evidence of disease; they are randomized to regorafenib for up to 12 months or to placebo surveillance. The main goal is to see if regorafenib improves relapse-free survival and disease control, with results analyzed by high-risk versus low-risk relapse groups. Key exclusions include prior VEGFR inhibitors, certain cardiovascular problems, active infections, HIV, hepatitis B/C, pregnancy, and other conditions that could affect safety or adherence. The study is currently recruiting.

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- This trial tests regorafenib plus best supportive care as maintenance therapy for high-grade bone sarcomas after standard treatment. - It is for patients aged 12 and older with confirmed high-grade bone tumors (e.g., osteosarcoma, Ewing, chondrosarcoma, UPS, leiomyosarcoma, angiosarcoma) who have evaluable residual disease that cannot be removed and did not progress after initial therapy. - Participants will receive regorafenib with BSC for up to 12 months to see if this approach can better delay progression, with progression-free rate as a key measure. - Key exclusions include prior VEGFR inhibitors, soft tissue sarcomas, certain cardiovascular problems, active infection, and pregnancy or breastfeeding.

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This trial tests whether interrupting aromatase inhibitor therapy is feasible and how it compares to continuing AI therapy in adults with locally advanced or metastatic low-grade endometrial stromal sarcoma (LGESS) who have disease controlled on AI. It is open-label and randomized, aiming to learn the effect on progression-free survival. It includes adults aged 18 and older with LGESS whose disease is controlled at randomisation while on AI for at least 24–36 months. Key exclusions include pregnancy or breastfeeding, use of other anticancer drugs, and significant cardiovascular, liver, kidney, or other major illnesses that could interfere with participation. Ancillary studies will explore predictive factors and collect sociobehavioral data from participants.

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HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors is being studied. Conditions: Neoplasms, Brain, Glioblastoma Multiforme, Glioblastoma of Cerebellum +30 • Eligibility: Inclusion Criteria: * Age ≥ 36 months and \< 22 years * Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive…. Goal: This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Phase/Status/Sponsor: Unknown phase; RECRUITING; M.D. Anderson Cancer Center.

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Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma is being studied. Conditions: Sarcoma • Eligibility: Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the…. Goal: The overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patients may struggle to tolerate side effects of the treatment including immune cell suppression. Phase/Status/Sponsor: Unknown phase; RECRUITING; University of Colorado, Denver.

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SABRE tests autologous CAR-T cells targeting B7-H3, combined with DNR-PRAME tumor antigen–specific T cells, given after lymphodepleting chemotherapy in children and young people with relapsed or refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor. It is a phase I dose-escalation study to determine safety and feasibility and to find the maximum tolerated dose by monitoring dose-limiting toxicities during the first 28 days after infusion. Up to 18 participants aged 1 to under 24 years will receive three dose levels and be followed during hospitalization and for at least 1 year, with longer follow-up planned. Key exclusions include known CNS disease, uncontrolled infection or HIV, pregnancy, and prior allogeneic stem cell transplant, among other safety criteria.

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This study tests whether infusing universal donor NK cells that are TGFβ-imprinted and expanded outside the body, with the chemotherapy gemcitabine and docetaxel, is safe and could improve outcomes for relapsed or refractory pediatric sarcomas. It enrolls children and young adults aged 2 to 40 with measurable relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or other soft tissue sarcomas. Researchers aim to learn about safety and efficacy, the 6-month progression-free survival, and how long the NK cells persist and relate to outcomes. Key exclusions include prior cellular therapies (such as CAR-T), active CNS metastases, pregnancy, HIV infection, and use of other investigational drugs.

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DESTINY-PANTUMOUR04 is being studied. Conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer +24 • Eligibility: Inclusion Criteria: 1. Adults aged ≥18 years 2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic…. Goal: This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US Phase/Status/Sponsor: Unknown phase; RECRUITING; AstraZeneca.

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This trial tests INBRX-109, a DR5-targeting antibody, in people with locally advanced or metastatic solid tumors, including sarcomas. It is a first-in-human, open-label, three-part phase 1 study to assess safety and to determine a dose for future use. Eligible participants include people aged 12-84 with Ewing sarcoma and 18-84 with other tumors, all with measurable disease; there are expansion groups for Ewing sarcoma with the classical fusion and for colorectal adenocarcinoma with limited prior therapy. Exclusions include prior DR5 agonist treatment, recent anticancer therapy, active liver disease, and active CNS tumors or HIV/HBV/HCV infection. The study is currently recruiting.

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This study tests lurbinectedin used alone to treat pediatric and young adult participants with relapsed or refractory Ewing sarcoma (and, in Phase 1, other previously treated solid tumors). The trial has two parts: Phase 1 will look at safety, tolerability, how the drug behaves in the body, the recommended Phase 2 dose, and initial effectiveness; Phase 2 will further assess how well it works and its safety in the target group. Eligible participants are children and young adults roughly aged 2 to 30 with a confirmed solid tumor and adequate organ function and general health. Important exclusions include QT prolongation, active CNS metastases requiring steroids, significant uncontrolled illness or recent intensive therapy, prior lurbinectedin or trial drugs, and recent live vaccines.

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Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials is being studied. Conditions: Breast Cancer, NOS, CNS Primary Tumor, NOS, Cervical Cancer, NOS +9 • Eligibility: Inclusion Criteria: Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any…. Goal: The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO. Phase/Status/Sponsor: Unknown phase; RECRUITING; Eastern Cooperative Oncology Group.

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This trial tests a new drug combo—Paclitaxel Polymer Micelles with gemcitabine and a targeted therapy (Lenvatinib for bone sarcoma or Anlotinib for soft tissue sarcoma)—in people with locally advanced unresectable or metastatic bone or soft tissue sarcomas whose disease has progressed after first-line therapy. It aims to find out how well the treatment can shrink tumors (objective response rate) and to learn about safety and how the treatment works in these cancers, with regular scans and blood tests to monitor progress. The study plans to enroll about 46 participants, split into two groups (23 bone sarcoma, 23 soft tissue sarcoma), ages 12 to 70. Key exclusions include uncontrolled infections, major heart or kidney problems, active brain metastases (unless well controlled), extensive liver tumor burden, certain infectious diseases, and other serious conditions that could interfere with participation.

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A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing is being studied. Conditions: Locally Advanced Alveolar Soft Part Sarcoma, Metastatic Alveolar Soft Part Sarcoma, Locally Advanced Non Small Cell Lung Cancer +7 • Eligibility: * INCLUSION CRITERIA: * Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab,…. Goal: Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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- This is a single-arm, multi-center trial testing romiplostim as a supportive care measure for patients with a new diagnosis of Ewing sarcoma receiving interval‑compressed chemotherapy. - It aims to learn whether romiplostim can prevent chemotherapy-induced thrombocytopenia (low platelets), whether it is safe to use with upfront Ewing sarcoma treatment, and whether it can be feasibly incorporated into standard regimens. - Eligible participants are patients over 1 year old with a new Ewing sarcoma diagnosis who are treated with interval‑compressed chemotherapy, and their informed consent (and assent when appropriate) is required. - Key exclusions include bone marrow–metastatic disease, certain extensive bone marrow–directed radiation or procedures, prior use of romiplostim or other platelet‑producing agents, and a history of immune thrombocytopenia–related treatments or related hematologic conditions.

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The Lu-TARGO trial tests LNTH-2403, a 177Lu-labeled radiopharmaceutical, for people with relapsed or refractory osteosarcoma. It is a non-randomized, open-label study that will measure how the drug distributes in the body (dosimetry), test increasing dose levels, and then expand a cohort to gather more data. Eligible participants include those with relapsed/refractory osteosarcoma who have progressed after at least one chemotherapy course, with age groups starting at 18 years (Phase 1) and then 12 years or older in later cohorts and Phase 2, and who meet imaging and performance criteria. Key exclusions include allergy to LNTH-2403 or its components, active infection or significant other illnesses, ongoing anti-cancer therapy, pregnancy or breastfeeding, HIV, active liver disease, recent major surgery, or inability to comply with study procedures.

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The SPEARHEAD-3 Pediatric Study is testing a treatment called afamitresgene autoleucel in children and teens with certain advanced cancers. It includes patients whose tumors express MAGE-A4 and who are HLA-A*02 positive, across cancers such as synovial sarcoma, MPNST, neuroblastoma, and osteosarcoma (ages 2-17 for synovial sarcoma; 2-21 for the other cancers). The study aims to assess safety and whether the treatment helps, after prior chemotherapy and with measurable disease before treatment. Key exclusions include HLA-A*02:05 positivity or similar A*02 variants, autoimmune disease, CNS metastases, active infections (HIV, HBV, HCV), pregnancy, significant cardiovascular disease, or another cancer not in remission.

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A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma is being studied. Conditions: Uveal Melanoma, Melanoma, Metastatic Uveal Melanoma +1 • Eligibility: Inclusion Criteria: Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma. * Patients will be eligible regardless of the number of prior systemic therapies received. *…. Goal: This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma. Phase/Status/Sponsor: Unknown phase; RECRUITING; Memorial Sloan Kettering Cancer Center.

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- The study tests a combo of AMXT 1501 and DFMO (eflornithine) in children and young adults up to age 21 with relapsed or refractory neuroblastoma, certain brain tumors (including DIPG), and some sarcomas. - The main goals are to find a safe, recommended dose of AMXT 1501 with DFMO, assess safety and tolerability, and learn whether the treatment shows activity by looking at responses and how long the disease stays under control. - The trial includes different age groups (adolescents and young adults 12 and older, and younger children under 12) with age-specific dose considerations. - Key exclusions include body surface area under 0.25 m2, current use of other investigational or anticancer drugs, active infection, or risk factors that would make safety monitoring unreliable.

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This Mayo Clinic-sponsored trial, currently recruiting, tests delivering cancer treatment at home versus in the clinic for adults with advanced cancer who are already receiving standard therapy. It aims to learn how the home-based approach affects patient experiences, preferences, comfort with home infusions, and overall quality of life compared with usual clinic care. The study also looks at safety of home administration with remote monitoring, and outcomes like emergency room visits, hospitalizations, and overall survival. Eligible participants are adults with various cancer types on eligible regimens, but those who need 24/7 assistance with daily activities, are currently inpatient, or have uncontrolled illness may be excluded.

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Intravital Microscopy in Human Solid Tumors is being studied. Conditions: Solid Tumor, Adult, Clinical Stage IV Gastric Cancer AJCC v8, Malignant Solid Neoplasm +20 • Eligibility: Inclusion Criteria: * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2 * Measurable tumor by direct visualization requiring surgical resection…. Goal: This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. Phase/Status/Sponsor: Unknown phase; RECRUITING; Mayo Clinic.

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The study will look at the molecular, cellular, and genetic features of several pediatric solid tumors (including neuroblastoma, osteosarcoma, retinoblastoma, Ewing sarcoma, soft tissue sarcomas, adrenocortical tumors, and liver cancers) using gene expression analysis, SNP/genomic testing, CGH, sequencing, and electron microscopy, and it will also create tumor cell lines and animal tumor models. It will study how T cells recognize tumors by comparing T cell receptors from blood and from tumor tissue, and it will examine methylation patterns and anti-tumor T cell responses before and after PD-1 inhibition. Eligible participants are children and young adults up to age 25 with suspected or known diagnoses of these cancers, from whom tissue may be collected at biopsy, surgery, bone marrow aspiration, or relapse, with informed consent at St. Jude or collaborating sites. Exclusion: patients who are positive for Hepatitis B, Hepatitis C, or HIV.

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This study tests the molecular and genetic basis of pediatric liver cancer by analyzing tumor tissue, blood, and saliva from affected children and their biological parents and siblings. It is for children under 21 who have had a liver tumor (benign or malignant) and their families. Researchers aim to learn how gene defects and gene function influence how these cancers develop and behave, to improve classification and future treatments. Exclusions include no prior or current treatment for a childhood liver tumor, and non-biological guardians or non-biological siblings.

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Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. is being studied. Conditions: Non-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck Cancer +2 • Eligibility: Inclusion Criteria: 1. Histologically or cytologically confirmed endometrial, colorectal, head \& neck, non-small cell lung cancer (NSCLC), or sarcoma 2. Patient with progressive, unresectable and/or advanced or metastatic…. Goal: Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, uterus, bladder, bones, blood, etc. Phase/Status/Sponsor: Unknown phase; RECRUITING; UNICANCER.

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A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer is being studied. Conditions: Cutaneous Squamous Cell Carcinoma, SCC - Squamous Cell Carcinoma, Basal Cell Carcinoma +16 • Eligibility: Inclusion Criteria: * Age 18 or over * Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two…. Goal: Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis. Phase/Status/Sponsor: Unknown phase; RECRUITING; Memorial Sloan Kettering Cancer Center.

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- This trial tests proton-spatially fractionated radiotherapy (P-SFRT) together with standard radiation therapy for newly diagnosed retroperitoneal soft tissue sarcoma. - It is for adults with untreated retroperitoneal soft tissue sarcoma that is at least 3 cm in size and who are planning neoadjuvant radiation and surgical removal. - Researchers aim to find the maximum tolerated dose of P-SFRT and to learn whether adding it before standard radiation and surgery can affect progression-free survival and overall survival. - Key exclusions include prior radiation to the area, certain sarcoma subtypes with standard chemotherapy, active infections, pregnancy, metastatic disease, and other safety-impacting conditions.

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- Mayo Clinic is testing three treatments—carbon ion therapy, surgery, and proton therapy—for pelvic bone sarcomas in people aged 15 and older who have newly diagnosed tumors and no distant metastases. - The study aims to see if carbon ion therapy improves patients’ reported quality of life compared with surgery, and whether it provides better local disease control than proton therapy. - Participants will fill out quality-of-life questionnaires before therapy, 2–4 months after therapy, 5–9 months after completion, and then annually for up to five years. - Key exclusions include receiving palliative treatment, recurrent disease, age under 15, prior radiation to the treatment area, distant metastases, benign pelvic bone tumors, and pregnancy or inability/unwillingness to consent or complete questionnaires.

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- This is a phase 2, recruiting study testing a combination of all-trans retinoic acid (ATRA) and cemiplimab in adults with metastatic or locally advanced, unresectable leiomyosarcoma (LMS) that has progressed after standard therapy. - It aims to learn how well the combo works by measuring objective responses and survival, using RECIST 1.1 and iRECIST, and to assess safety. - Treatment starts with ATRA for 3 cycles, then cemiplimab IV every 3 weeks for three cycles, followed by cemiplimab alone; cohorts are guided by a Bayesian Optimal Phase II design (BOP2). - Eligible participants are adults with LMS with measurable disease and adequate organ function; prior PD-1/PD-L1 therapy is allowed; key exclusions include active autoimmune disease, symptomatic CNS metastases, cirrhosis (Child-Pugh B), pregnancy, and recent major surgery or uncontrolled infection.

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The trial is testing two detection methods, RT-qPCR and ddPCR, to find minimal residual disease in cryopreserved ovarian or testicular tissue. It focuses on tissues from children who were treated for neuroblastoma or Ewing sarcoma during infancy. The goal is to compare the sensitivity and specificity of these methods to identify tumor cells and determine the most reliable approach for safe future use of the preserved tissue. There are no exclusion criteria listed.

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This is a French multicenter, retrospective, observational study that is currently recruiting to study rare primary liver cancers. It includes adults 18 and older with histologically confirmed hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, or hepatic angiosarcoma diagnosed after January 1, 2018. The study aims to describe clinical, histological and radiological features, collect tumor tissue and blood, and evaluate how treatments used in real-world care have performed to help determine the best sequencing of therapies. Key exclusions are lack of social security and no access to tumor tissue; living participants must consent to research for ancillary studies.

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Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study is being studied. Conditions: Glioblastoma Multiforme, Adult, Glioblastoma or Gliosarcoma, Glioblastoma, Adult • Eligibility: Inclusion Criteria: * At least 18 years of age * Newly-diagnosed glioblastoma (IDH wild-type) * Never received prior chemotherapy * Never received radiotherapy to the head or neck…. Goal: The study aims to investigate the prognostic significance of olfactory function in patients with glioblastoma. We are examining olfactory function at various points during therapy and correlating the results with survival data. Phase/Status/Sponsor: Unknown phase; RECRUITING; Sied Kebir.

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The trial tests how quality of life changes over two years after endoscopic endonasal skull base surgery. It follows adults scheduled for this surgery at Ohio State University, with assessments before surgery and up to 24 months afterward. The study aims to measure quality of life using modern reconstruction techniques and to understand healing timelines and factors linked to worse outcomes. Participants must be 18 or older and able to consent and follow the study, and exclusions include prisoners, non-English speakers, and those not expected to survive to the 2-year follow-up.

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HTL0039732 is a new drug being tested in adults with advanced solid tumors, given alone or with atezolizumab or other approved cancer therapies. This is a first-in-human, early-phase study to find safe dose levels and to learn how the drug may affect tumors. In Phase 1 Part A, HTL0039732 is given as a monotherapy; in Phase 1 Part B it is given with atezolizumab, and Phase 2a will test the dose in specific cancer types where PGE2/EP4 signaling may be important. The study will also look at safety and potential side effects of HTL0039732 alone and in combination. Key exclusions include recent cancer therapies or immunotherapies, active autoimmune disease needing systemic treatment in the past 2 years, HIV or hepatitis B/C infection, pregnancy or breastfeeding, prior EP4 inhibitors, and receipt of live vaccines within 4 weeks before enrollment for parts involving immunotherapy.

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This is an observational, prospective study by the Italian Sarcoma Group to collect data on patients with localized high-grade osteosarcoma treated under the AIEOP/ISG OS 2021 plan. It aims to learn about patients’ demographic, clinical, surgical, pathological and molecular characteristics, the treatments they receive, and their outcomes. The study is currently recruiting. Eligibility includes people diagnosed with high-grade osteosarcoma of the arms or legs, age 40 or younger, localized disease (skip metastases allowed) and adequate organ function who give informed consent. Exclusions include the presence of metastases, periosteal or parosteal or secondary osteosarcoma, or any medical condition that would prevent receiving the recommended treatment.

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A Study of MT-4561 in Patients With Various Advanced Solid Tumors is being studied. Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer +13 • Eligibility: Main Inclusion Criteria: Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable…. Goal: This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts. Phase/Status/Sponsor: Unknown phase; RECRUITING; Tanabe Pharma America, Inc..

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hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) is being studied. Conditions: Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Supratentorial Glioblastoma +1 • Eligibility: Inclusion Criteria: * Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or near gross total resection (resection of \>85%…. Goal: This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Phase/Status/Sponsor: Unknown phase; RECRUITING; Leland Metheny.

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BostonGene and Exigent Genomic INsight Study is being studied. Conditions: Breast Cancer, Non-small Cell Lung Cancer, Melanoma +1 • Eligibility: Inclusion Criteria: * Patients must have a confirmed malignancy of: Locally recurrent, unresectable, or metastatic breast cancer or; Unresectable stage III or metastatic non-small cell lung cancer or;…. Goal: The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Phase/Status/Sponsor: Unknown phase; RECRUITING; BostonGene.

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ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss is being studied. Conditions: Gynaecological Cancers • Eligibility: Inclusion Criteria: 1. Histologically confirmed progressive or recurrent gynaecological carcinomas of the following histological subtypes: Cohorts 1A, 1B, 2 and 3: * Clear cell (Ovarian, endometrial or endometriosis-related,…. Goal: ATARI trial tests the ATR inhibitor drug ceralasertib (AZD6738) alone and in combination with either a PARP inhibitor drug called olaparib, or an anti-PD-L1 immunotherapy called durvalumab (MEDI4736) in patients with relapsed gynaecological cancers to assess the response in groups of patients selected based on their cancer cell subtype and the presence of an abnormality in the ARID1A gene. Phase/Status/Sponsor: Unknown phase; RECRUITING; Institute of Cancer Research, United Kingdom.

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Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies is being studied. Conditions: Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer +4 • Eligibility: Inclusion Criteria: * Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent to participate in the study must be performed before any procedure's protocol…. Goal: The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies. Phase/Status/Sponsor: Unknown phase; RECRUITING; Celon Pharma SA.

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This trial tests a combination therapy using a PARP inhibitor, PD-1 immunotherapy, and SBRT radiation for metastatic or advanced bone and soft tissue sarcoma. It is for people aged 10 to 70 with high-grade sarcoma that has spread or cannot be fully removed, who have had at least one prior systemic treatment and have not used a PARP inhibitor before. The study aims to see how well this combination works and how safe it is, and to explore tumor biomarkers to guide future personalized treatment. Exclusions include a second cancer within the last five years, active autoimmune disease requiring systemic therapy, prior anti-PD-1/PD-L1 therapy, HIV, pregnancy or breastfeeding, and recent live vaccines.

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Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer is being studied. Conditions: Fallopian Tube Carcinosarcoma, Primary Peritoneal Carcinosarcoma, Recurrent Fallopian Tube Carcinoma +13 • Eligibility: Inclusion Criteria: * Age \>= 18 years * Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent…. Goal: This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. Phase/Status/Sponsor: Unknown phase; RECRUITING; Mayo Clinic.

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The trial tests PET imaging using a radioactive form of methionine to evaluate tumors in children and young adults with cancer. It aims to find out how often MET PET can visualize tumors at diagnosis and whether MET uptake relates to tumor grade. The study also looks at how MET distributes in normal organs and how MET PET findings compare with MRI and FDG-PET CT over time. The trial is sponsored by St. Jude Children’s Research Hospital and is currently active but not recruiting. Eligible participants are patients under St. Jude care with known or suspected cancer; key exclusions include having more than six MET PET scans in the past year or an inability to give informed consent (and lactation in women of childbearing age).

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This study tests dinutuximab beta added to chemotherapy for patients under 18 with GD2-positive osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma that is advanced or metastatic after progression on first-line chemotherapy. Participants will receive 6 cycles of dinutuximab beta with 6–8 cycles of chemotherapy during induction, without switching regimens, and tumor response will be measured by RECIST 1.1 after every 2 cycles and at the end. The primary objective is to determine the efficacy and safety of this immunotherapy-plus-chemotherapy approach. The trial plans to enroll about 40 patients and randomize roughly 10; exclusion criteria include withdrawal of consent or safety/ethical exclusion by the investigator.

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The LINNOVATE trial tests a combination of lurbinectedin with ipilimumab and nivolumab for adults with locally advanced unresectable or metastatic soft tissue sarcoma. It is an open-label study that gradually increases the lurbinectedin dose while fixed doses of the two antibodies are given, to find a safe dose and learn about safety and potential effectiveness. In the dose-escalation phase, phase 1 includes participants who have been treated before, while phase 2 would enroll participants who have not been treated previously. Key exclusions include untreated brain metastases, autoimmune disease, prior anti-CTLA-4 or anti-PD-1 therapy, pregnancy, HIV or active hepatitis, and significant organ problems.

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- This study tests whether adding selinexor to gemcitabine helps people with selected advanced soft-tissue sarcomas (UPS, LMS, ASPS) and osteosarcoma. - It is for adults 18–80 whose disease has progressed after prior therapy, with measurable disease and good functioning (ECOG 0–1). - The trial starts with Phase I to find a safe dose, then moves to Phase II with four tumor-type groups; most groups are randomized to selinexor plus gemcitabine or gemcitabine alone, except the ASPS cohort. - Key eligibility exclusions include three or more prior chemotherapy lines, prior selinexor or gemcitabine, pregnancy, active infection, and brain metastases unless treated and stable.

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This trial tests ABSK043, an oral PD-L1 inhibitor, in people with unresectable or metastatic angiogenic sarcomas, specifically intimal sarcoma, head and neck angiosarcoma, or epithelioid hemangioendothelioma. It aims to see if ABSK043 helps these cancers, to evaluate its safety and tolerability, and to identify biomarkers in tumor tissue or blood that could predict response or side effects. About 20 participants are planned to take part at the Princess Margaret Cancer Centre. Key exclusions include active autoimmune disease requiring systemic therapy, prior PD-1/PD-L1 therapy, active brain metastases, HIV or active hepatitis, pregnancy, active infections, and recent cancer treatments or other investigational drugs.

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A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors is being studied. Conditions: Solid Tumours, Sarcoma, HNSCC +9 • Eligibility: Inclusion Criteria: 1. Histologically or cytologically confirmed disease, locally advanced or metastatic: For Phase 1a: Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are…. Goal: The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. Phase/Status/Sponsor: Unknown phase; RECRUITING; Epkin.

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This study tests preoperative hypofractionated radiation therapy given before conservative surgery for soft tissue sarcoma of the limbs or trunk in older or "fragile" patients. It is a phase II, multicenter, non-randomized trial enrolling up to 48 evaluable patients, with follow-up for up to 3 years after treatment. The goal is to learn how this preoperative radiotherapy affects wound healing and safety in this population. Eligible participants must have histologically confirmed limb or trunk soft tissue sarcoma and need neoadjuvant or adjuvant radiotherapy, and be aged ≥70 or 65–70 with a fragility designation, able to consent. Key exclusions include retroperitoneal, ORL or visceral sarcomas; prior radiotherapy in the area; metastatic disease; chemotherapy; need for total amputation; MRI contraindications; and other conditions that could affect participation.

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This is a longitudinal cohort study to see if cancer treatment accelerates early aging in adolescents and young adults with cancer, by measuring aging markers before therapy and one year later. It includes patients aged 18-39 with a confirmed cancer diagnosis who are about to start systemic therapy with curative intent. The main goal is to see how the senescence marker P16 changes over one year, and it also looks at SASP, vascular markers, and cardiovascular risk factors related to treatment and patient/tumor characteristics. Measurements are taken at two visits and include blood tests and a physical exam (weight, height, waist-hip ratio, blood pressure); key exclusions are inability to understand consent, treatment with immune checkpoint inhibitors or anti-angiogenic therapy, and prior systemic therapy or radiotherapy for another cancer (with limited exceptions).

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This trial tests the safety and manufacturing feasibility of giving a patient’s own B7-H3-targeted CAR T cells (B7-H3CART) by IV infusion for relapsed or refractory solid tumors. It is for children and young adults aged 2 to 30 with tumors that have not responded to standard therapies, including neuroblastoma, sarcomas, Wilms tumor, and other solid tumors. The study uses a 3+3 dose-escalation design to find a safe dose and learn about how to manufacture the product and how well patients tolerate it. B7-H3 expression is not required (tumor tissue may be analyzed), and key exclusions include active infections, certain heart conditions, untreated brain metastases, pregnancy, and other active cancers or systemic immunosuppression.

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- This study tests the combination of nivolumab and ipilimumab in adults with rare cancers to see if it can shrink tumors or slow their growth. - It includes many different rare tumor types in separate groups, plus a PD-L1–amplified cohort that uses nivolumab alone, and it measures how often tumors respond using standard criteria. - The trial also looks at safety, overall survival, and progression-free survival across cohorts. - Eligible participants must have progressed after prior therapy and generally cannot have active brain metastases or uncontrolled autoimmune disease; some cohorts have additional specific requirements or exclusions.

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The study tests adding hydroxychloroquine to a chemotherapy combo of gemcitabine and docetaxel for people with recurrent or treatment-refractory osteosarcoma. It aims to find the maximum tolerated dose and to see if the regimen improves disease control at 4 months compared with historic results. Researchers will also look at tumor response, survival outcomes, safety, pharmacokinetics, and related biomarkers and imaging changes. Eligible participants have osteosarcoma that has recurred or not responded to standard therapy and measurable disease; key exclusions include prior gemcitabine or docetaxel, pregnancy or potential pregnancy, HIV, active infection, major heart or eye conditions, and other significant health issues.

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This pediatric MATCH trial tests the drug ivosidenib (AG-120) in children and adolescents with advanced solid tumors, CNS tumors, lymphomas, or histiocytic disorders that have IDH1 mutations and have not responded to prior treatment. The study aims to see how often tumors shrink or disappear (objective response rate) and to learn about progression-free survival and safety in this group. Participants are aged 12 months to 21 years and must have measurable disease along with other health criteria. Ivosidenib is given by mouth once daily in 28-day cycles, for up to 2 years, to study its pharmacology and biomarkers of response. Key exclusions include pregnancy or breastfeeding, use of strong CYP3A4 inhibitors or inducers, prior exposure to IDH1 inhibitors, and receiving another investigational or anti-cancer drug at enrollment.

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- The study tests weekly irinotecan liposomes in people with relapsed or metastatic Ewing sarcoma to see if it is safe and whether it can help control the cancer. - It is for patients whose disease has recurred or progressed after standard first-line chemotherapy and who have measurable disease and adequate organ function. - The trial uses a Bayesian dose-finding design to identify an appropriate weekly dose. - Key exclusions include QTc prolongation over 480 ms, pregnancy or breastfeeding, known allergy to irinotecan liposomes, and having another active cancer or a serious uncontrolled illness.

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The study tests a five-day preoperative radiation course for soft tissue sarcoma (in the extremity, trunk, or retroperitoneum) to see if it is safe and effective compared with the standard 25-day treatment. It is for adults 18 and older who have been offered preoperative radiation and surgery as part of standard care and have adequate performance status and a life expectancy of at least 6 months. The trial aims to learn whether the shorter radiation course can achieve similar treatment outcomes with acceptable safety. Exclusions include prior radiation to the treated area, use of other investigational cancer drugs, planned concurrent chemotherapy or targeted/immunotherapy with radiation, and pregnancy.

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This trial tests whether umbilical cord blood–derived natural killer (NK) cells are safe and effective in children with high-risk or relapsed/refractory soft tissue sarcoma. It is a single-arm, open-label study enrolling about 40 patients under 18, who will receive eight NK cell doses over 3 months, with follow-up of up to 3 years to study safety, efficacy, and how the NK cells behave in the body. The goal is to learn if this NK cell therapy can help these patients and to understand its pharmacokinetics and pharmacodynamics. Key exclusions include symptomatic brain metastasis, active infection requiring antimicrobial therapy, and significant cardiovascular or other serious organ diseases that could affect safety or results.

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This trial tests whether adding mifamurtide to post-operative chemotherapy improves outcomes for newly diagnosed high-risk osteosarcoma patients. It compares post-operative chemotherapy alone to post-operative chemotherapy plus mifamurtide in a multicenter, randomized, open-label design. Participants are people aged 2 to 50 with high-grade osteosarcoma who already had pre-operative chemotherapy and surgery and are considered high risk (metastases at diagnosis or poor histological response). Exclusions include low-grade osteosarcoma, active HIV or hepatitis infections, pregnancy, heart function issues, and other medical conditions that would preclude chemotherapy.

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This is a Phase 2 pilot study testing OMO-103, a Myc inhibitor, given by intravenous infusion to see if it is safe and has anti-tumor activity in people with advanced high-grade osteosarcoma. It is open-label, unicentric, and single-arm, enrolling about 10 evaluable patients to assess anti-tumor activity and to study safety, tolerability, pharmacokinetics and pharmacodynamics. Eligible participants are people aged 12 years and older with histologically confirmed, advanced high-grade osteosarcoma not suitable for curative local treatment, whose disease has progressed after standard chemotherapy; at least 30% will be under 18, with the first three aged 12–15 under extra safety monitoring. Treatment uses 6.5 mg/kg of OMO-103 weekly by IV infusion until progression or intolerable toxicity. Key exclusions include active uncontrolled infection or HIV/HBV/HCV infection, recent systemic cancer therapy or radiation, another active malignancy, pregnancy or breastfeeding, or other conditions that could interfere with participation.

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Lipid Mediators & Cancer: Montelukast, SPM, and Almonds is being studied. Conditions: Colorectal Cancer, Sarcoma, Brain Tumors +2 • Eligibility: Inclusion Criteria: 1. Newly diagnosed individuals with stages I-IV colorectal or ovarian cancer, grade 1 and 2 endometrial cancer, as well as those with brain tumors or sarcoma.…. Goal: The purpose of this study is to create a prospective investigation to examine the effects of montelukast, almonds/almond oil, and specialized pro-resolving mediators (SPMs) on lipid profiles and tumor-associated macrophages (TAMs) in cancer patients (colorectal cancer, sarcoma, brain tumors, endometrial cancer, and ovarian cancer). The focus will be on assessing changes in lipid mediator concentrations, TAM reprogramming, and immune cell function in treated versus untreated patients. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; University of South Florida.

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- This study tests whether injecting Talimogene laherparepvec (TVEC) into tumors together with preoperative external beam radiation therapy is safe and may help treat locally advanced soft tissue sarcomas. - It is for adults with unresectable STS subtypes, including undifferentiated pleomorphic sarcoma, myxofibrosarcoma, and malignant peripheral nerve sheath tumor, whose tumors are injectable and suitable for radiation. - The treatment plan uses weekly TVEC injections during neoadjuvant radiotherapy, with surgery scheduled about 4–6 weeks after radiation ends to remove the tumor. - Key exclusions include immunodeficiency or active infections (e.g., HIV, hepatitis B/C), pregnant or breastfeeding women, autoimmune disease, recent other cancers, CNS metastases, and certain anticoagulant or medical conditions.

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Natural Progesterone for the Treatment of Recurrent Glioblastoma is being studied. Conditions: Gliosarcoma, Recurrent Glioblastoma • Eligibility: Inclusion Criteria: * Patients must have pathologic confirmation of a glioblastoma or gliosarcoma diagnosis at initial surgery or second or later surgery * Patients may have had up…. Goal: This early phase I trial identifies the best dose, possible benefits and/or side effects of natural progesterone in treating patients with glioblastoma that has come back (recurrent). Progesterone is a type of hormone made by the body that plays a role in the menstrual cycle and pregnancy. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Emory University.

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- This phase Ib trial is testing whether regorafenib can be given safely with the standard chemotherapy for newly diagnosed Ewing sarcoma that has spread to multiple sites beyond the lungs or pleura. - It is for patients aged 2 to under 50 who have metastatic disease and are fit to receive the full multimodal treatment. - The study aims to find out if adding regorafenib is feasible and how to dose it during induction chemotherapy and consolidation chemotherapy, using different dose levels and timing around surgery or radiotherapy. - Key exclusions include disease limited to the lungs/pleura, pregnancy, prior ES treatment other than surgery, significant heart problems or uncontrolled high blood pressure, and other health issues that could interfere with treatment. - The trial is currently not recruiting.

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This pediatric MATCH trial tests selpercatinib, an RET pathway inhibitor, in children and adolescents with advanced solid tumors, lymphomas, or histiocytic disorders that have activating RET gene alterations. The study aims to learn how often tumors shrink or disappear (objective response rate) and how long patients stay progression-free, as well as how tolerable the drug is. Participants are ages 12 months to 21 years with measurable disease and must have recovered from prior therapy; they must not have previously received selpercatinib or other RET inhibitors. Selpercatinib is given by mouth twice daily in 28-day cycles for up to 26 cycles (about 2 years), with regular imaging and safety monitoring. Key exclusions include pregnancy, certain drug interactions (e.g., strong CYP3A4 inhibitors/inducers), recent major surgery, active infection, and uncontrolled medical conditions.

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- This pediatric MATCH trial tests tipifarnib in children and young people aged 12 months to 21 years whose advanced solid tumors, lymphoma, or histiocytic disorders have an HRAS gene alteration. - The main goal is to see how many patients have a tumor shrinkage or disappearance (objective response) with tipifarnib. - The study also looks at progression-free survival and how well the drug is tolerated in kids and teens. - It will explore biomarkers that might predict who responds and how tumor DNA in blood changes over time. - Key exclusions include pregnancy or breastfeeding, and not being eligible if you’re on other investigational drugs or certain interacting medications.

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This randomized study tests whether adding ganitumab, a drug that blocks the IGF-1R pathway, to standard multiagent chemotherapy improves outcomes for newly diagnosed metastatic Ewing sarcoma. It is for patients whose cancer has spread to the lungs, bones, bone marrow, or other sites. The main goal is to see if event-free survival is better with ganitumab, and it also looks at overall survival and treatment toxicity, plus many exploratory biomarker and imaging studies to understand how the treatment works. Key exclusions include disease limited to regional lymph nodes, tumors in the brain or spinal cord, prior chemotherapy or radiation, pregnancy or contraception requirements for females of childbearing potential, diabetes, and chronic high-dose corticosteroid use.

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Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme is being studied. Conditions: Glioblastoma, Gliosarcoma • Eligibility: Inclusion Criteria: * Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if…. Goal: This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; National Cancer Institute (NCI).

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This study tests whether biodegradable magnesium metal clips are safe and effective for closing surgical margins during radical surgery for malignant bone and soft tissue tumors. It compares using magnesium clips to conventional methods like electrocautery and sutures. Participants are adults (roughly 18 to 65 years old) with certain bone or soft tissue sarcomas who have completed standard chemotherapy and need en bloc tumor resection. The study aims to learn about safety, healing at the surgical margins, and overall surgical outcomes with the magnesium clips. Key exclusions include severe dysfunction of the heart, liver, kidney, lung, or brain; pregnancy or breastfeeding; autoimmune or infectious conditions or immunosuppressive therapy; recent participation in another trial; or other conditions the researchers deem unsuitable.

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- This not-yet-recruiting study tests whether a preoperative Tru-cut biopsy can accurately determine the histology of sonographically atypical myometrial lesions in women planned for uterus-preserving surgery or hysterectomy. - It is a single-arm, prospective, multicenter cohort enrolling about 250 adult women with an atypical myometrial lesion seen on ultrasound. - The main goal is to compare biopsy results with the final postoperative pathology to see if TCB can guide safer, tailored surgical management and assess impact on quality of life. - Key exclusions include pregnancy, age under 18, contraindications or inability to perform the biopsy, refusal to participate, and other factors that would prevent biopsy or surgery.

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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) is being studied. Conditions: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer +13 • Eligibility: Inclusion Criteria: * Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement * For patients enrolled via…. Goal: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Hoffmann-La Roche.

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Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options is being studied. Conditions: Solid Tumors, CNS Tumors • Eligibility: Inclusion Criteria: 1. Disease status: * Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 * Phase 2 portion: * Part…. Goal: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Hoffmann-La Roche.

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The trial tests zanzalintinib as a single therapy for adults with advanced or metastatic bone sarcomas. It splits participants into four groups by tumor type: osteosarcoma, Ewing sarcoma, chondrosarcoma, and other bone sarcomas. It aims to learn how long patients live without the cancer getting worse (PFS) at 12 weeks (16 weeks for osteosarcoma), the rate of tumor shrinkage, overall survival, and the safety of the drug, with some exploratory biomarker work. Key exclusions include prior exposure to zanzalintinib, untreated brain metastases, significant heart or liver disease, pregnancy, and certain infection or bleeding risks.

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This study tests EGFR-targeted CAR T cell therapy in children and young adults with relapsed or refractory non-CNS solid tumors that express EGFR. It has two arms: Arm A uses EGFR CAR T cells alone, and Arm B adds a CD19-targeting component. It is a phase I, open-label, non-randomized trial to assess safety and feasibility, determine the maximum tolerated dose, describe the toxicity, and see how long the CAR T cells persist and act against tumors. Eligible participants include those with EGFR-expressing non-CNS solid tumors that are recurrent or refractory; early enrollees are ages 15–30, with later enrollees ages 1–30. Key exclusions include active infection, other active cancers, active CNS disease, pregnancy, and GVHD or significant immunosuppression; if severe toxicity occurs, cetuximab or trastuzumab may be used to help eliminate the CAR T cells.

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Aerosolized Aldesleukin in Treating Patients With Lung Metastases is being studied. Conditions: Metastatic Malignant Neoplasm in the Lung, Metastatic Melanoma, Metastatic Osteosarcoma +5 • Eligibility: Inclusion Criteria: * Patients with diagnosis of advanced cancer with lung metastases; patients with no prior therapy are eligible if there is no known superior alternative medical therapy;…. Goal: This phase I/II trial studies the side effects and best dose of aerosolized aldesleukin and to see how well it works in treating patients with cancer that has spread from the original tumor to the lungs. Biological therapies, such as aerosolized aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; M.D. Anderson Cancer Center.

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This phase II trial tests the combination of oleclumab and durvalumab in adults (and older teens in one cohort) with sarcoma that has recurred, is refractory, or has metastasized, including angiosarcoma, dedifferentiated liposarcoma, and osteosarcoma. It aims to learn how well the treatment works by measuring tumor shrinkage at 4 months and by estimating event-free survival for osteosarcoma patients, with additional safety and survival data collected. The study will also collect biomarker and immune-system data to understand how the therapy affects tumors and immune cells. Key exclusions include prior anti-PD-1/PD-L1 or anti-CD73 therapy, active autoimmune disease, untreated CNS metastases, recent anticancer therapy, and other conditions that could interfere with participation.

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Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma is being studied. Conditions: Metastatic Alveolar Soft Part Sarcoma, Unresectable Alveolar Soft Part Sarcoma • Eligibility: Inclusion Criteria: * Patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery. Diagnosis of malignancy must be confirmed by the…. Goal: This phase II trial studies how well atezolizumab or atezolizumab plus bevacizumab works in treating patients with alveolar soft part sarcoma that has not been treated, has spread from where it started to other places in the body (advanced) and cannot be removed by surgery (unresectable). Atezolizumab works by unblocking the immune system, allowing the immune system cells to recognize and then attack tumor cells. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; National Cancer Institute (NCI).

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- This trial tests treatments for Ewing sarcoma family tumors (ESFT) and desmoplastic small round cell tumor (DSRCT) in children and young people. - Participants are split into Group A (standard-risk ESFT under 14, non-pelvic, no metastasis) who get standard chemotherapy with planned local control, and Group B (higher-risk ESFT or DSRCT, including those 14 or older or with pelvic or metastatic disease) who receive a window therapy with temsirolimus, temozolomide, and irinotecan, followed by induction chemotherapy and maintenance. - The study aims to estimate the initial response rate to the Group B window therapy and to measure overall survival, progression-free survival, time to progression, and local control outcomes. - Key exclusions include pregnancy or breastfeeding and a history of another cancer (except certain non-melanoma skin cancers); participants must not have had prior chemotherapy or radiation.

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C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N) is being studied. Conditions: Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma +4 • Eligibility: Procurement Inclusion Criteria: 1. Evaluable neuroblastoma with persistent or relapsed disease 1. Recurrent disease following completion of aggressive multi-drug frontline therapy. 2. Progressive disease during aggressive multi-drug frontline…. Goal: This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or another cancer that expresses a substance on the cancer cells called GD2. The cancer has either come back after treatment or did not respond to treatment. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Baylor College of Medicine.

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Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma is being studied. Conditions: Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV +3 • Eligibility: Inclusion Criteria: * Glioblastoma or gliosarcoma (recurrent or newly diagnosed). * Karnofsky Performance Status 60 or greater. * Phase 0: Candidate for clinically indicated re-resection or biopsy of…. Goal: This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; University of Michigan Rogel Cancer Center.

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This randomized, multicenter trial tests whether adding zoledronic acid to standard chemotherapy improves outcomes for people with high‑grade osteosarcoma, compared with chemotherapy alone, and it plans to enroll about 440 patients. It uses different chemotherapy regimens based on age, and some treatment arms include zoledronic acid before and after surgery. The study aims to learn whether the combination improves progression-free survival, and it also looks at overall survival, histologic response, toxicity, and quality of life. All participants have surgery after initial chemotherapy, and subsequent treatment is guided by how much tumor remains. Eligibility requires histologically confirmed high‑grade osteosarcoma and adequate organ function; key exclusions include low‑grade, small cell, maxillary, or extra‑osseous osteosarcoma, metastases not removable, prior chemotherapy or radiotherapy, dental problems, and pregnancy or related contraceptive issues.

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The ANTARES study is testing whether nivolumab, a PD-1 blocker, can work in people with advanced or metastatic rare tumors that express PD-L1 (CPS ≥ 10), regardless of tumor type. It is a phase II basket trial, enrolling adults whose cancers have higher PD-L1 expression after standard treatments have failed. Treatment can last up to 12 months, and researchers will look at objective responses, progression-free survival, and biomarkers like PD-L1, ctDNA, and microvesicles. Exclusions include prior immunotherapy, pregnancy or breastfeeding, active infection, autoimmune disease (with limited exceptions), and uncontrolled CNS metastases, among other health criteria.

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This study tests regorafenib, a broad-spectrum tyrosine kinase inhibitor, in young patients ages 9 to 21 with refractory primary bone tumors like Ewing sarcoma or osteosarcoma. It aims to see whether adding regorafenib to standard treatment can improve outcomes and to use molecular testing to guide therapy and understand prognosis. Participants must have progressed or relapsed after initial therapy and be able to swallow tablets, with informed consent and a life expectancy of at least 12 weeks. Exclusions include prior exposure to regorafenib, pregnancy or breastfeeding, and health conditions that could increase risk or interfere with results.

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Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma is being studied. Conditions: Pediatric Solid Tumor, Pediatric Lymphoma, Pediatric Brain Tumor +5 • Eligibility: Inclusion Criteria: All Patients * Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or…. Goal: The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Cellectar Biosciences, Inc..

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Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors is being studied. Conditions: MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma +28 • Eligibility: Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of PD1 mRNA high-expression…. Goal: This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; SOLTI Breast Cancer Research Group.

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- The trial tests image-guided radiation therapy (IGRT) to treat pediatric musculoskeletal tumors, aiming to target the tumor precisely while sparing healthy tissue. - It is for people up to 25 years old with musculoskeletal tumors of the bone or soft tissue that require radiation to the primary tumor site (including Ewing family, rhabdomyosarcoma, and other soft tissue sarcomas). - The study will estimate local tumor control with IGRT, compare its effectiveness to older non-image-guided radiation, and look at patterns of failure and long-term disease control (over 5 years). - It also investigates how radiation affects normal tissues, such as growth plates and muscles, to identify dose thresholds and track changes over time. - Eligibility notes include that females of childbearing potential must have a negative beta-HCG test, and patients should not have had prior therapeutic irradiation to the primary site (except for a brief emergent dose that can be accounted for in analysis).

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ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme is being studied. Conditions: Glioblastoma, Gliosarcoma • Eligibility: Inclusion Criteria: -Patients must have histologically confirmed diagnosis of a recurrent/progressive WHO grade IV malignant gliomas (glioblastoma multiforme and gliosarcoma) and meet the following inclusion criteria: 1. Age…. Goal: This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World Health Organization (WHO) grade IV malignant gliomas, GBM). Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Epitopoietic Research Corporation.

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The study, currently not recruiting, tests whether CDH6 protein levels in osteosarcoma and Ewing’s sarcoma tissue can serve as a prognostic biomarker and help monitor treatment response. It includes patients over 12 years old with newly diagnosed high‑grade osteosarcoma or Ewing’s sarcoma who have not yet received first‑line chemotherapy. Researchers will measure CDH6 expression in tumor samples collected at diagnosis and around surgery to see if changes reflect chemotherapy sensitivity and prognosis. Exclusion criteria include inability to receive standardized chemotherapy and surgery at the center, not agreeing to standard follow‑up, or any condition that could harm participation.

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Summary not available yet.

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- The study tests botensilimab, an Fc-engineered anti-CTLA-4 monoclonal antibody, alone and in combination with balstilimab (anti-PD-1) in advanced solid tumors to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, and to identify the maximum tolerated dose and the recommended Phase 2 dose. - It is for adults with refractory, advanced cancers and will enroll up to about 550 evaluable participants across multiple cancer types, including NSCLC, melanoma, hepatocellular cancer, and others. - The trial uses a 3+3 dose-escalation design to determine dosing and will also explore safety, PK/PD, and potential clinical activity at doses deemed potentially effective. - Key exclusions include active brain metastases unless treated with specific criteria, active autoimmune disease requiring systemic therapy, active infection, pregnancy or breastfeeding, and certain recent or concurrent cancer therapies (prior CTLA-4 therapy may be allowed in some indications with sponsor agreement).

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- The study tests GD2-CART01, a CAR T-cell therapy made from the patient’s own T cells that targets the GD2 protein, in children and young adults with high‑risk or relapsed/refractory neuroblastoma and a small group of other GD2‑positive tumors. - It has two parts: Phase I to find a safe dose and Phase II to expand and assess efficacy. - Eligible participants will have T cells collected, engineered into GD2-CART01, receive a lymphodepleting regimen, and then a single infusion of the CAR T cells that includes a safety switch to stop activity if needed. - The study follows patients for up to 5 years after treatment; key exclusions include pregnancy, severe infections, HIV, hepatitis B or C, and certain organ dysfunction or recent conflicting therapies.

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Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors is being studied. Conditions: Solid Tumor, Adult, Epithelial Ovarian Cancer, Small Cell Lung Carcinoma +9 • Eligibility: Key Inclusion Criteria: * Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic…. Goal: This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Cybrexa Therapeutics.

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Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics is being studied. Conditions: Retroperitoneal Sarcoma, Retroperitoneal Fibrosis • Eligibility: Inclusion Criteria: * Patients of any age or gender. * CT scans confirming the presence of a retroperitoneal mass. * Confirmed diagnosis of retroperitoneal fibrosis, sarcoma or other…. Goal: A retrospective study utilizing archived CT scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Heidelberg University.

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A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors. is being studied. Conditions: Late Effects, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma +6 • Eligibility: 1. males and females aged 18-65 years; 2. Diagnosis and management at CLB for one of the following cancers: Hodgkin's lymphoma, aggressive non-Hodgkin's lymphoma, acute myeloid leukemia and…. Goal: INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Centre Leon Berard.

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Pembrolizumab in Treating Patients With Recurrent Glioblastoma is being studied. Conditions: Recurrent Glioblastoma, Recurrent Gliosarcoma • Eligibility: Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial * Have histologically confirmed World Health Organization grade IV malignant glioma (glioblastoma or…. Goal: This phase II trial studies the effects of pembrolizumab on the body, or pharmacodynamics, in patients with glioblastoma that has come back. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; M.D. Anderson Cancer Center.

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- This trial tests cabozantinib s-malate as a treatment for osteosarcoma or Ewing sarcoma that has relapsed or grown after standard therapy. - The study aims to see if cabozantinib can shrink tumors or stop their growth, with a focus on six-month responses measured by RECIST criteria. - It also looks at longer-term outcomes such as progression-free and overall survival, plus safety. - The trial is sponsored by the National Cancer Institute and is currently active but not recruiting. - Key exclusions include prior cabozantinib, recent cancer therapies, untreated brain metastases or major heart problems, pregnancy or breastfeeding, and HIV infection on antiretroviral therapy.

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- This is a randomized trial testing cabozantinib s-malate plus nivolumab versus nivolumab alone in adults with advanced, recurrent, or metastatic endometrial cancer that has progressed after platinum-based therapy. - The study aims to learn whether the combination can improve progression-free survival and overall response rate, and to look at overall survival and safety. - It will also examine biomarkers such as PD-L1, T-cell infiltrates, and MSI/MMR status to see how they relate to outcomes. - Key exclusions include untreated or uncontrolled brain metastases (with some allowed if previously treated and controlled), prior cabozantinib, active infections or significant cardiovascular issues, pregnancy or breastfeeding, and the requirement for a baseline biopsy.

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Summary not available yet.

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Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma is being studied. Conditions: Pancreatic Ductal Adenocarcinoma, KRAS G12D, KRAS G12V +12 • Eligibility: Inclusion Criteria: * Has at least 1 of the 7 KRAS/NRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D) * The following must be met: (1) the…. Goal: This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201. Phase/Status/Sponsor: Unknown phase; AVAILABLE; Elicio Therapeutics.

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Summary not available yet.

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- This study tests adding abemaciclib to the chemotherapy drugs irinotecan and temozolomide for Ewing's sarcoma that has come back or did not respond to treatment. - It is for children and young adults with Ewing's sarcoma or Ewing's sarcoma-like tumors and is part of the CAMPFIRE master protocol to speed up developing new treatments. - The trial aims to learn whether this combination improves outcomes and safety, with participation lasting about 11 months or longer depending on how the tumor responds. - Key exclusions include severe uncontrolled illness, active infections (including HIV or hepatitis), pregnancy or breastfeeding, prior CDK4/6 inhibitor use, and progression during prior irinotecan/temozolomide.

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Summary not available yet.

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- This study tests whether the biomarker TOPO2A can predict how soft tissue sarcoma patients will respond to the chemotherapy drugs doxorubicin or Doxil. - It is for adults with soft tissue sarcoma whose next planned treatment is single-agent doxorubicin or Doxil, and patients receiving olaratumab with doxorubicin may also join. - TOPO2A will be measured in tumor tissue, and treatment response will be checked every two cycles using standard criteria, continuing until progression, prohibitive toxicity, or the cumulative dose of 450 mg/m2 is reached. - Key exclusions include pregnancy or breastfeeding, and participation is not allowed with other investigational agents or other chemotherapy or radiation therapy (except olaratumab with doxorubicin).

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Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma is being studied. Conditions: Osteosarcoma, Ewing Sarcoma • Eligibility: Inclusion Criteria: * Osteosarcoma and Ewing sarcoma first diagnosis * No previous chemotherapy treatment * ≥ 12 years old * Able to understand the questionnaire * No malignant…. Goal: Osteosarcoma and Ewing sarcoma treatment has not changed in the last 30 years. For other types of cancer the epidemiologic and prognostic correlations between dietary behavior, lifestyle and metabolic alterations (i.e.obesity, insulin-resistance) are well known (breast cancer, prostate cancer, colon cancer). Phase/Status/Sponsor: Unknown phase; UNKNOWN; Istituto Ortopedico Rizzoli.

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Chidamide Combined With Toripalimab in Sarcoma is being studied. Conditions: Sarcoma • Eligibility: Inclusion Criteria: 1. Patients voluntarily participated in this study and signed the informed consent; 2. The pathology diagnosed with at least one measurable lesion according to RECIST 1.1…. Goal: Soft tissue sarcoma is a relatively rare malignant tumor with an incidence of about 1-2/100,000. The best way to obtain evidence-based medical evidence is to participate in clinical trials with new drugs (especially targeted drugs and immunotherapy). Phase/Status/Sponsor: Unknown phase; UNKNOWN; Sun Yat-sen University.

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A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents is being studied. Conditions: Cancer, Tumor, Solid, Malignant Neoplasm +7 • Eligibility: Inclusion Criteria: 1. Informed consent signed by the subject prior to conducting study-specific procedures. 2. Male or female subjects ≥ 18 and ≤ 100 years of age. 3.…. Goal: This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with advanced solid tumors. Phase/Status/Sponsor: Unknown phase; UNKNOWN; OncoResponse, Inc..

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Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA) is being studied. Conditions: Leiomyosarcoma • Eligibility: Inclusion Criteria: Patients may be included in the study if they meet all of the following criteria: 1. Age ≥ 16 years. Patients under 18 years, should be…. Goal: The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients. Phase/Status/Sponsor: Unknown phase; UNKNOWN; Philogen S.p.A..

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TAEST16001 in the Treatment of Soft Tissue Sarcoma is being studied. Conditions: Soft Tissue Sarcoma • Eligibility: Inclusion Criteria: 1. The informed consent form (ICF) (genotype and tumor antigen screening and primary screening) should be signed before any research related operation; 2. Age ≥ 18…. Goal: This study is an open, single arm, dose increasing early clinical study, which is divided into two parts: "3 + 3" designed dose escalation study and extended group study. The purpose of this study is to evaluate the safety, tolerance, PK, PD characteristics, and preliminary efficacy of TAEST16001 immunotherapy in the treatment of patients with solid tumor maily containing soft tissue sarcoma whose tumor antigen NY-ESO-1 expression is positive (HLA-A \* 02:01). Phase/Status/Sponsor: Unknown phase; UNKNOWN; Sun Yat-sen University.

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This study tests an oral drug called AG-120 (ivosidenib) in people with IDH1-mutated advanced solid tumors, including glioma. It enrolls adults whose disease has recurred or progressed after standard therapy and includes several expansion groups such as cholangiocarcinoma, chondrosarcoma, non-enhancing glioma, and other IDH1-mutated tumors. The study first uses a dose-escalation phase to find the maximum tolerated dose and a recommended Phase II dose, then expands at that dose to evaluate safety, tolerability, and any signs of clinical activity. The trial aims to learn how safe the drug is, how it behaves in the body, and whether it shows anticancer activity at the chosen dose. Key exclusions include recent anticancer therapy or investigational agents, certain heart conditions or QT prolongation risk, pregnancy, and untreated or recently treated brain metastases.

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Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy is being studied. Conditions: Melanoma, Gastrointestinal Neoplasms, Genitourinary Cancer +2 • Eligibility: Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Diagnosed with non-small cell lung cancer (NSCLC) OR melanoma AND initiating therapy with single…. Goal: This research aims to identify clinical strategies to manage adverse events during immune checkpoint inhibitor therapy by (1) determining the impact of checkpoint inhibitors on metabolism through major CYP enzymes and (2) identifying associations between pro-inflammatory cytokine concentrations and negative clinical outcomes during checkpoint inhibitor therapy. Phase/Status/Sponsor: Unknown phase; COMPLETED; Indiana University.

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Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1) is being studied. Conditions: Recurrent Malignant Glioma, Glioblastoma Multiforme of Brain, Gliosarcoma of Brain +1 • Eligibility: Inclusion Criteria: Patients must have histologically or cytologically confirmed recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma. Prior therapy. Patients must have failed a course of external beam radiotherapy…. Goal: The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when re-administered into the brain where the tumor is located. Phase/Status/Sponsor: Unknown phase; TERMINATED; University of Alabama at Birmingham.

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WeCanManage. An mHealth Self-management Tool is being studied. Conditions: Breast Cancer, Head and Neck Cancer, Sarcoma • Eligibility: Inclusion Criteria: Usability Testing of the WeCanManage High Fidelity Prototype * Age 18 or older * Diagnosis of breast cancer, head and neck cancer or sarcoma * Completion…. Goal: Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported Outcomes. Using a pre-post, single arm feasibility design with cancer survivors with disabilities Phase/Status/Sponsor: Unknown phase; COMPLETED; University of Illinois at Chicago.

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Tazemetostat Expanded Access Program for Adults With Solid Tumors is being studied. Conditions: Epithelioid Sarcoma (Ex-US Only), Spindle Cell Sarcoma, Sinonasal Carcinoma +17 • Eligibility: Inclusion Criteria: 1. Age (at the time of consent): \>18 years of age. 2. They are unable to participate in tazemetostat clinical trials for their condition. 3. Can…. Goal: Patients with a diagnosis listed under "conditions" below are eligible to be considered for the EAP. These conditions must be serious or life-threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Phase/Status/Sponsor: Unknown phase; NO_LONGER_AVAILABLE; Epizyme, Inc..

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Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types is being studied. Conditions: Bile Duct Cancer, Gall Bladder Cancer, Breast Cancer +6 • Eligibility: Inclusion Criteria: * Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused…. Goal: Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Phase/Status/Sponsor: Unknown phase; SUSPENDED; University of Florida.

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Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients is being studied. Conditions: Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma +14 • Eligibility: Inclusion Criteria: \- Exclusion Criteria: \-. Goal: AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Phase/Status/Sponsor: Unknown phase; AVAILABLE; AVM Biotechnology Inc.

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Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma is being studied. Conditions: Glioblastoma, Gliosarcoma • Eligibility: Inclusion Criteria: * Signed informed consent form (ICF). * Ability and willingness to comply with the requirements of the study protocol. * Have histologically confirmed World Health Organization…. Goal: This phase I/II trial studies the side effects and how well atezolizumab works in combination with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; COMPLETED; M.D. Anderson Cancer Center.

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Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab is being studied. Conditions: Glioblastoma, Glioblastoma Multiforme, Gliosarcoma +2 • Eligibility: * General Inclusion Criteria * Patients with histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS). Patients will be eligible if the original histology was low-grade glioma and…. Goal: Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors is being studied. Conditions: Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST) +9 • Eligibility: Inclusion Criteria: 1. Voluntarily signed and dated written informed consent prior to any specific-study procedure. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status…. Goal: Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage. Phase/Status/Sponsor: Unknown phase; COMPLETED; PharmaMar.

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A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 is being studied. Conditions: Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma +8 • Eligibility: Inclusion Criteria: INT230-6 monotherapy Cohorts EC2 and EC3, combination with KEYTRUDA® cohort DEC2 and combination with Yervoy cohort FEC. Where criteria diverge the DEC2 and FEC specific criteria…. Goal: This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Phase/Status/Sponsor: Unknown phase; COMPLETED; Intensity Therapeutics, Inc..

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NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma is being studied. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma +1 • Eligibility: Inclusion Criteria: * Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide…. Goal: NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Phase/Status/Sponsor: Unknown phase; COMPLETED; Case Comprehensive Cancer Center.

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A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma is being studied. Conditions: Brain and Central Nervous System Tumors • Eligibility: Key Inclusion Criteria: All participants 1. Age ≥ 18 years old. 2. Confirmed diagnosis of glioblastoma (WHO Grade IV). 3. Agreement to provide archival tumor tissue for exploratory…. Goal: The primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma. Phase/Status/Sponsor: Unknown phase; COMPLETED; BeiGene USA, Inc..

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The Registry of Oncology Outcomes Associated with Testing and Treatment is being studied. Conditions: Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer +73 • Eligibility: Inclusion Criteria: * Patient or representative provides written informed consent * Patient is diagnosed with advanced malignancy * Patient is willing to be treated for this malignancy according…. Goal: This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. Phase/Status/Sponsor: Unknown phase; COMPLETED; Taproot Health.

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Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma is being studied. Conditions: Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma • Eligibility: Inclusion Criteria: * Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnosis of lower grade gliomas that…. Goal: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; COMPLETED; Jonsson Comprehensive Cancer Center.

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A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas is being studied. Conditions: Pilomyxoid Astrocytoma, Pilocytic Astrocytoma, Glioma, Astrocytic +9 • Eligibility: Inclusion Criteria: 1. Age \> 1 year of age and ≤ 21 years of age 2. Diagnosis 2.1. Group A - Low-grade Glioma Group: Histology: Biopsy-proven: * Pilocytic…. Goal: This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Phase/Status/Sponsor: Unknown phase; COMPLETED; Julie Krystal.

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Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children is being studied. Conditions: Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma +8 • Eligibility: Inclusion Criteria: * Patients must have a recurrent supratentorial WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma, ependymoma) or WHO Grade IV…. Goal: The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). Phase/Status/Sponsor: Unknown phase; COMPLETED; Istari Oncology, Inc..

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Vaccine Therapy in Treating Patients With Metastatic Cancer is being studied. Conditions: Lung Cancer, Adult Soft Tissue Sarcoma, Colorectal Cancer +8 • Eligibility: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically documented metastatic cancer of one of the following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell lung cancer Breast carcinoma Sarcoma…. Goal: RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors is being studied. Conditions: Supratentorial Neoplasms, Malignant, Malignant Glioma, Glioblastoma +4 • Eligibility: Inclusion Criteria: * Age ≥ 36 months and \< 19 years * Pathologically proven malignant supratentorial brain tumor (including glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal…. Goal: This study is a clinical trial to determine the safety of injecting G207 (a new experimental virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication and tumor cell killing, will also be tested. Phase/Status/Sponsor: Unknown phase; COMPLETED; Gregory K. Friedman, MD.

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Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme is being studied. Conditions: Brain and Central Nervous System Tumors • Eligibility: DISEASE CHARACTERISTICS: * Histopathologically confirmed glioblastoma multiforme * Grade IV disease by WHO classification * Newly diagnosed disease * Initial diagnostic surgery or biopsy performed within the past…. Goal: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phase/Status/Sponsor: Unknown phase; COMPLETED; Canadian Cancer Trials Group.

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Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme is being studied. Conditions: Brain and Central Nervous System Tumors • Eligibility: DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioblastoma multiforme, meeting 1 of the following criteria: * Newly diagnosed disease AND meets the following criteria: * Has undergone prior surgery…. Goal: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Phase/Status/Sponsor: Unknown phase; COMPLETED; NCIC Clinical Trials Group.

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Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers is being studied. Conditions: Glioblastomas, Sarcoma, Astrocytoma +2 • Eligibility: * INCLUSION CRITERIA FOR CHILDREN: * Patients diagnosed with a high-risk/high-grade cancer (e.g., high-grade brain tumors, relapsed/refractory acute lymphoblastic leukemia, acute myeloid leukemia, high-grade sarcoma) characterized by poor…. Goal: Background: People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors is being studied. Conditions: Solid Tumor • Eligibility: Inclusion Criteria: 1. Advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible…. Goal: This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion. Phase/Status/Sponsor: Unknown phase; TERMINATED; Actym Therapeutics, Inc..

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Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases is being studied. Conditions: Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma +9 • Eligibility: Inclusion Criteria: * Patients may have a Wilms tumor, Ewing Sarcoma, Rhabdomyosarcoma or any other metastatic pediatric malignancy; patients may have a single or multiple pulmonary metastases at…. Goal: This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Phase/Status/Sponsor: Unknown phase; COMPLETED; Ann & Robert H Lurie Children's Hospital of Chicago.

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Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer is being studied. Conditions: Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative +64 • Eligibility: Inclusion Criteria: * Newly diagnosed patients for the following conditions * Colon cancer stage III and IV * Rectal cancer stage II, III, IV * Glioblastoma multiforme (brain)…. Goal: This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management. Phase/Status/Sponsor: Unknown phase; COMPLETED; Stanford University.

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Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers is being studied. Conditions: Cervical Adenocarcinoma, Cervical Adenosarcoma, Cervical Adenosquamous Carcinoma +45 • Eligibility: Inclusion Criteria: * Age \>= 18 years * Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma * Melanoma cohort only: measurable disease defined as…. Goal: This phase I trial studies the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix, endometrium, ovary, fallopian tube or peritoneal cavity. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Phase/Status/Sponsor: Unknown phase; COMPLETED; Mayo Clinic.

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Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas is being studied. Conditions: Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Diffuse Intrinsic Pontine Glioma +3 • Eligibility: Inclusion Criteria: * Patients with newly diagnosed DIPGs, defined as tumors with a pontine epicenter and diffuse involvement of the pons, are eligible without histologic confirmation * Patients…. Goal: This phase I trial studies the side effects and the best dose of adavosertib when given together with local radiation therapy in treating children with newly diagnosed diffuse intrinsic pontine gliomas. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma is being studied. Conditions: Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma • Eligibility: Inclusion Criteria: * Willing and capable of undergoing apheresis for collection of mononuclear cells * Histologically confirmed GBM (grade 4 astrocytoma) NOTE: gliosarcomas and other grade 4 astrocytoma…. Goal: This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Mayo Clinic.

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