Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
NCT06333899 · High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma
RecruitingThe goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
PhaseEARLY_Phase 1
TypeInterventional
Age1 Year – 21 Years
WhereAurora, Colorado, United States + 17 more
SponsorNationwide Children's Hospital
▾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 + 17 more
SponsorRigel Pharmaceuticals
▾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 Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
NCT05843253 · High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma
RecruitingThe goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.
PhasePhase 2
TypeInterventional
Age12 Months – 39 Years
WhereAurora, Colorado, United States + 19 more
SponsorNationwide Children's Hospital
▾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 Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
NCT04323046 ·
Glioblastoma, Malignant Glioma,
Recurrent Glioblastoma RecruitingThis phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PhasePhase 1
TypeInterventional
Age6 Months – 25 Years
WhereBirmingham, Alabama, United States + 19 more
SponsorSabine Mueller, MD, PhD
▾Tap for detailsClick for full details — eligibility, all locations, contacts EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT06556563 ·
Glioblastoma RecruitingThis is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 92 more
SponsorNovoCure GmbH
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
NCT03970447 ·
Glioblastoma RecruitingGlioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\*).
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 62 more
SponsorGlobal Coalition for Adaptive Research
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
NCT06894979 · Childhood Astrocytoma, Childhood Diffuse Intrinsic Pontine Glioma, Childhood Diffuse Midline Glioma
RecruitingThis phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to repair deoxyribonucleic acid damage caused by cancer treatments, such as radiation therapy. This may help overcome resistance to therapy seen in these cancers and therefore lead to increased death of cancer cells. Radiation therapy uses high energy x-rays or particles to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
PhasePhase 1
TypeInterventional
Age12 Months – 22 Years
WhereBirmingham, Alabama, United States + 19 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma
Recruiting* To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \[18F\]Fluciclovine and 18F-FDG PET. * To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism. * To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States + 1 more
SponsorAbramson Cancer Center at Penn Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
NCT04732065 · Diffuse Midline Glioma (DMG),
Glioblastoma, Recurrent Ependymoma
RecruitingThis phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.
PhasePhase 1
TypeInterventional
Age2 Years – 21 Years
WhereSan Francisco, California, United States + 5 more
SponsorSabine Mueller, MD, PhD
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
NCT06388733 ·
Glioblastoma, GBM, Brain Neoplasms, Adult, Malignant
RecruitingThe goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is: Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. * study drug (Niraparib) or * comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: * Complete study visits as scheduled * Complete a diary to record study medication
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 94 more
SponsorIvy Brain Tumor Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with "standard array mapping" (based on regular contrast enhanced MRI) or an "alternative (more precise) array mapping" based on sophisticated state of the art MRI techniques including "whole brain spectroscopy". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.
PhaseNA
TypeInterventional
Age22 Years
WherePhiladelphia, Pennsylvania, United States + 1 more
SponsorAbramson Cancer Center at Penn Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Targeted Pediatric High-Grade Glioma Therapy
NCT05839379 · High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma
RecruitingThe goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
Phase—
TypeObservational
Age12 Months – 39 Years
WhereAurora, Colorado, United States + 20 more
SponsorNationwide Children's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
RecruitingThis is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
NCT06973096 ·
Glioblastoma RecruitingThis is an open-label phase 1 study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma, without evidence of disease recurrence/progression following completion of initial radiotherapy.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts