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 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 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 Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
NCT05039281 ·
Recurrent Glioblastoma, Recurrent Gliosarcoma
RecruitingThis phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 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 + 17 more
SponsorRigel Pharmaceuticals
▾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 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 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 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
SponsorPatrick Wen, MD
▾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 SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
NCT05303519 · Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma
RecruitingThis is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 44 more
SponsorNuvation Bio Inc.
▾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 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 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 Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
NCT04623931 · Anaplastic Astrocytoma, IDH-Wildtype, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma
RecruitingThis phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more 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, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.
PhasePhase 2
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 + 16 more
SponsorDebiopharm International SA
▾Tap for detailsClick for full details — eligibility, all locations, contacts Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
NCT04555577 ·
Glioblastoma, Gliosarcoma
RecruitingThis phase I trial investigates the side effects and best dose of Peposertib, and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Peposertib may further stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, 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. Giving Peposertib with radiation therapy may work better than radiation therapy alone in treating patients with glioblastoma or gliosarcoma.
PhasePhase 1
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 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
Age3 Years – 21 Years
WhereBirmingham, Alabama, United States + 2 more
SponsorM.D. Anderson Cancer Center
▾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