Clinical Trials for Childhood Brain Stem Glioma

Trials 1-25 of 28
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  • H3.3K27M-specific Peptide Vaccine and Poly ICLC in Treating Patients with Newly Diagnosed HLA-A2 Positive, H3.3K27M Positive Diffuse Intrinsic Pontine Glioma or Other Newly Diagnosed Gliomas including Spinal Cord Tumors

    This pilot phase I trial studies the side effects of H3.3K27M-specific peptide vaccine and how well it works with poly ICLC in treating patients with newly diagnosed HLA-A2 positive, H3.3K27M positive diffuse intrinsic pontine glioma or other newly diagnosed glioma including spinal cord tumors. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Poly ICLC may boost the immune system. Giving H3.3K27M-specific peptide vaccine and poly ICLC may work better at treating HLA-A2 positive, H3.3K27M positive glioma.
    Location: 16 locations

  • Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE)

    Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.
    Location: 15 locations

  • WEE1 Inhibitor AZD1775 and Local Radiation Therapy in Treating Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas

    This phase I trial studies the side effects and the best dose of WEE1 inhibitor AZD1775 when given together with local radiation therapy in treating children with newly diagnosed diffuse intrinsic pontine gliomas. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Giving WEE1 inhibitor AZD1775 with local radiation therapy may work better than local radiation therapy alone in treating diffuse intrinsic pontine gliomas.
    Location: 22 locations

  • Panobinostat in Treating Younger Patients with Diffuse Intrinsic Pontine Glioma

    This phase I trial studies the side effects and best dose of panobinostat in treating younger patients with diffuse intrinsic pontine glioma. Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 10 locations

  • Pembrolizumab in Treating Younger Patients with Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma

    This phase I trial studies the side effects and best dose of pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas (brain tumors that are generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas (brain stem tumors), brain tumors with a high number of genetic mutations, ependymoma or medulloblastoma that have come back, progressed, or have not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.
    Location: 11 locations

  • An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies

    The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies
    Location: 10 locations

  • Phase 1 / 2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers

    This is a Phase 1 / 2, multi-center, open-label study designed to evaluate the safety and efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK fusion cancers treated with a prior TRK inhibitor.
    Location: 12 locations

  • CD40 Agonistic Monoclonal Antibody APX005M in Treating Pediatric Patients with Recurrent or Refractory Brain Tumors

    This phase I trial studies the side effects and best dose of CD40 agonistic monoclonal antibody APX005M in treating pediatric patients with brain tumors that have come back or do not respond to treatment. Immunotherapy with CD40 agonistic monoclonal antibody APX005M, may induce changes in the body’s immune system, and may interfere with the ability of tumor cells to grow and spread.
    Location: 8 locations

  • Fimepinostat in Treating Younger Patients with Relapsed or Refractory Solid Tumors, Central Nervous System Tumors, or Lymphoma

    This phase I trial studies the side effects of fimepinostat in treating younger patients with solid tumors, central nervous system tumors, or lymphoma that has come back or does not respond to treatment. Fimepinostat may stop the growth of cancer or tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

    This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.
    Location: 5 locations

  • A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors or DIPG

    This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex in the pediatric population.
    Location: 4 locations

  • Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas (INTELLANCE 2)

    This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme. The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population. Adult enrollment has been completed and the study is now only recruiting for pediatric participants.
    Location: 4 locations

  • Ribociclib and Everolimus in Treating Children with Recurrent or Refractory Malignant Brain Tumors

    This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, 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 ribociclib and everolimus may work better at treating malignant brain tumors.
    Location: 3 locations

  • Abemaciclib and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Recurrent or Refractory Solid Tumors, or Malignant Brain Tumors

    This phase I trial studies the side effects and best dose of abemaciclib when given together with radiation therapy in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a type of central nervous system tumor that forms from glial [supportive] tissue of the brain and spinal cord), or solid tumors that have come back (recurrent) or does not respond to treatment (refractory), or malignant brain tumors. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy may be a better treatment in patients with diffuse intrinsic pontine glioma, solid tumors, or malignant brain tumors.
    Location: 3 locations

  • A Study of Pomalidomide (CC-4047) Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors

    A Phase 2 study that will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to < 21 years with recurrent or progressive primary brain tumors. The study will consist of 4 parallel groups, one for each of the following primary brain tumor types: high-grade glioma, medulloblastoma, ependymoma and DIPG. A Simon's Optimal two-stage study design will be applied to each group.
    Location: 2 locations

  • Trial of Afatinib in Pediatric Tumours

    Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort / Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort / Phase II part to assess clinical anti-tumour activity in included tumour types
    Location: 3 locations

  • GDC-0084 after Radiation Therapy in Treating Pediatric Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Glioma

    This phase I trial studies the side effects and best dose of GDC-0084 when given after radiation therapy in treating pediatric patients with newly diagnosed diffuse intrinsic pontine glioma or diffuse midline glioma. GDC-0084 may stop the growth of tumor cells by reducing the levels of certain proteins needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. It is not yet known whether giving GDC-0084 after radiation therapy may work better in treating patients with diffuse intrinsic pontine glioma or diffuse midline glioma.
    Location: St. Jude Children's Research Hospital, Memphis, Tennessee

  • Volitinib in Treating Participants with Recurrent or Refractory Primary CNS tumors

    This phase I trial studies the best dose and side effect of volitinib in treating participants with primary central nervous system (CNS) tumors that have come or does not respond to treatment. Volitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Lurie Children's Hospital-Chicago, Chicago, Illinois

  • MTX110 by Convection-Enhanced Delivery in Treating Participants with Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

    This phase I / II trial studies the side effects of panobinostat nanoparticle formulation MTX110 (MTX110) in treating participants with newly-diagnosed diffuse intrinsic pontine glioma. Panobinostat nanoparticle formulation MTX110 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • ONC201 in Pediatric H3 K27M Gliomas

    This is a multicenter, open-label, four arm, dose escalation, phase I study of oral ONC201 in pediatric patients with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and recurrent / refractory H3 K27M gliomas. Arm A will define the RP2D for single agent ONC201 in pediatric patients with glioma who are positive for the H3 K27M mutation (positive testing in CLIA laboratory) and have completed at least one line of prior therapy. This will allow for recurrent patients and also patients who have not yet recurred, but have completed radiation and will inevitably recur based on prior clinical experience and the literature. Arm B will define the RP2D for ONC201 in combination with radiation in pediatric patients with newly diagnosed DIPG. Arm C will determine intratumoral drug concentrations and biomarker expression in pediatric patients with midline gliomas. Arm D will determine H3 K27M DNA levels and drug concentrations in the CSF of pediatric H3 K27M-mutant glioma patients.
    Location: 3 locations

  • Dasatinib and Everolimus in Treating Children with Newly Diagnosed, Recurrent, or Progressive High-Grade Glioma with PDGFR Alterations

    This phase II trial studies how well dasatinib and everolimus work in treating children with high-grade glioma with PDGFR alterations that is newly diagnosed, has come back, or is growing, spreading or getting worse. Dasatinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Liposomal Irinotecan in Treating Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma

    This phase I trial studies the side effects and best dose of liposomal irinotecan in treating children with newly diagnosed diffuse intrinsic pontine glioma. Liposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors

    This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation significantly enhanced survival by driving a vigorous, tumordirected inflammatory response. This data provided the rationale for the companion adult phase 1 trial using indoximod (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the clinic for children with brain tumors. This study will provide a foundation for future pediatric trials testing indoximod combined with radiation and temozolomide in the up-front setting for patients with newly diagnosed central nervous system tumors.
    Location: Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia

  • Vorinostat and Temsirolimus with or without Radiation Therapy in Treating Younger Patients with Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma

    This phase I trial studies the side effects and best dose of temsirolimus when given together with vorinostat and with or without radiation therapy in treating younger patients with newly diagnosed or progressive diffuse intrinsic pontine glioma, a tumor that arises from the middle portion of the brain stem. Vorinostat and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving temsirolimus and vorinostat with or without radiation therapy may be a better treatment for younger patients with diffuse intrinsic pontine glioma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Simvastatin, Topotecan Hydrochloride, and Cyclophosphamide in Treating Younger Patients with Relapsed and / or Refractory Solid and CNS Tumors

    This phase I trial studies the side effects and best dose of simvastatin when given together with topotecan hydrochloride and cyclophosphamide in treating younger patients with solid and central nervous system (CNS) tumors that have returned (relapsed) and / or that do not respond to treatment (refractory). Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride and cyclophosphamide, 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 simvastatin together with topotecan hydrochloride and cyclophosphamide may be a better treatment for solid and CNS tumors.
    Location: Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia


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