Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
NCT04479696 ·
Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma
RecruitingThis trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
NCT04094610 · Locally Advanced Solid Tumors, Metastatic Solid Tumors,
Lymphoma RecruitingPhase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
PhasePhase 1 / Phase 2
TypeInterventional
Age25 Years
WhereLos Angeles, California, United States + 67 more
SponsorTurning Point Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
NCT04427384 · Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary
RecruitingThe objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
Phase—
TypeObservational
AgeAny
WherePhoenix, Arizona, United States + 53 more
SponsorGT Medical Technologies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase1 Clinical Trial Evaluating Locoregional Delivery Of Engineered NK Cells Containing IL13Ra And EGFvIII Chimeric Antigen Receptor (CAR), IL-21 Secretion And Deleted TGF-BetaR2 And NR3C1 In Recurrent Glioblastoma
NCT07579208 · Phase 1, NK Cell, IL13Ra
RecruitingTo find the best method of administering NK cells in patients with recurrent glioblastoma.
PhasePhase 1
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
RecruitingThe primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm. The primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development. The Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States + 15 more
SponsorDebiopharm International SA
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
NCT05941507 · Advanced Solid Tumors
RecruitingThis is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 7 more
SponsorLigaChem Biosciences, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
RecruitingThe FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 8 more
SponsorBoston Scientific Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
NCT03596086 ·
Glioblastoma Multiforme, Astrocytoma, Grade III
RecruitingStudy to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorDavid Baskin MD
▾Tap for detailsClick for full details — eligibility, all locations, contacts HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
RecruitingThis 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. Funding Source- FDA OOPD
PhasePhase 1
TypeInterventional
Age36 Months – 22 Years
WhereBirmingham, Alabama, United States + 2 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Anti-GD2 ADC M3554 in Advanced Solid Tumors
NCT06641908 · Advanced Solid Tumor
RecruitingThe purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 10 more
SponsorEMD Serono Research & Development Institute, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
NCT02977780 ·
Glioblastoma RecruitingThis research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 11 more
SponsorDavid Reardon, MD
▾Tap for detailsClick for full details — eligibility, all locations, contacts MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
NCT03896568 · IDH1 wt Allele, Recurrent Anaplastic Astrocytoma,
Recurrent Glioblastoma RecruitingThis phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.
PhasePhase 1
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \[CB\]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR3C1- cells are genetically changed immune cells that may help to control the disease.
PhasePhase 1
TypeInterventional
Age12 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Olutasidenib and Temozolomide in HGG
NCT06161974 · High Grade Glioma, Astrocytoma, Astrocytoma, Grade III
RecruitingThe goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
PhasePhase 2
TypeInterventional
Age12 Years – 39 Years
WhereAurora, Colorado, United States + 19 more
SponsorRigel Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
NCT03603405 ·
Glioblastoma, Anaplastic Astrocytoma
RecruitingStudy to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorThe Methodist Hospital Research Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma
RecruitingThe body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T-cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat participants with cancers. They have shown promise, but have not been strong enough to cure most participants. The study team has found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carries the participants traits) into T cells that will make them recognize cancer cells and kill them. In the lab, the study team has made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein found on the participants brain tumor. This CAR is called GPC3-CAR. To make this CAR more effective, the study has also added a gene that includes IL15. IL15 is a protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15. This study will test T cells with the IL15 GPC3-CAR (GO-CART T cells) in participants with GPC3-positive brain tumors. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The study team will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The study team will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 (GO-CART T cells) in participants with GPC3-positive brain tumors. The GO-CART T cells are an investigational product not approved by the Food and Drug Administration.
PhasePhase 1
TypeInterventional
Age21 Years – 70 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
RecruitingThe purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 7 more
SponsorOrbus Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
RecruitingThe brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 55 more
SponsorCarThera
▾Tap for detailsClick for full details — eligibility, all locations, contacts DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
RecruitingThe goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses * Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: \- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
PhasePhase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 17 more
SponsorDiakonos Oncology Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts