Clinical Trials for Childhood Brain Stem Glioma

Trials 1-25 of 28
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  • Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent / Refractory Solid Tumors

    This study will evaluate palbociclib in combination with chemotherapy (temozolomide with irinotecan and topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors. The main purpose of this study is to evaluate the safety of palbociclib in combination with chemotherapy in order to estimate the maximum tolerated dose. Pharmacokinetics and efficacy of palbociclib in combination with chemotherapy will be evaluated.
    Location: 23 locations

  • Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

    Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent / refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent / refractory solid tumors including Ewing sarcoma / peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.
    Location: 22 locations

  • Fimepinostat in Treating Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma, or Recurrent High-Grade Glioma

    This early phase I trial studies how well fimepinostat works in treating patients with newly diagnosed diffuse intrinsic pontine glioma, or medulloblastoma, or high-grade glioma that have come back (recurrent). Fimepinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 14 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 (recurrent) or do not respond to treatment (refractory). 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: 11 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 (recurrent), progressed, or have not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread.
    Location: 11 locations

  • REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma

    Phase 1: - To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors - To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or CNS tumors Phase 2 (Efficacy Phase): - To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) - To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG) - To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG - To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation - To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG - To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG - To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG
    Location: 13 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

  • 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

  • ONC201 in Pediatric H3 K27M Gliomas

    This is a multicenter, open-label, seven 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. Arm E will determine the RP2D for single agent ONC201 administered as a liquid formulation in Ora-Sweet to patients with DIPG and / or H3 K27M glioma. Arm F is a dose expansion cohort to confirm the safety and estimate the efficacy in recurrent H3 K27M-mutant glioma population at the RP2D. Arm G will define the RP2D for single agent ONC201 given on two consecutive days of each week in pediatric patients with glioma who are positive for the H3 K27M mutation and have completed at least one line of prior therapy.
    Location: 5 locations

  • Marizomib Alone and in Combination with Panobinostat for the Treatment of Diffuse Intrinsic Pontine Glioma

    This phase I trial investigates the side effects and how well marizomib alone and in combination with panobinostat works in treating children with diffuse intrinsic pontine glioma. Marizomib and panobinostat may stope the growth of tumor cells by blocking some of the enzymes needed for cell growth. Marizomib alone and then in combination with panobinostat may shrink or slow the growth of cancer cells in children with diffuse intrinsic pontine glioma.
    Location: 3 locations

  • A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma

    In this research study the investigators want to learn more about the safety of the study drug, PTC596 has when taken during radiation. The investigators also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors. The investigators are asking people to be in this research study who have been diagnosed with a high grade glioma (HGG) including diffuse intrinsic pontine glioma (DIPG) to be in the research, because they have scheduled to have radiation to treat their cancer. The study is divided into two parts. The goal of the first part is to find the dose of PTC596 that can be given with radiation without causing serious side effects. The purpose of this surgical study is to test the amount of a study drug that may be found in the tumor and blood when given prior to and during a planned surgery for removal of the recurrent tumor. The goals of the first part: - Find the highest safe dose of PTC596 that can be given together with radiation therapy without causing severe side effects; - Learn what kind of side effects can be caused by PTC596 with radiation therapy; - Learn more about the pharmacology of PTC596; - Learn more about the biological effects of PTC596 on the cells in their body including any changes to the tumor DNA; - Determine whether PTC596 with radiation therapy is a beneficial treatment for their tumor; - Determine if there are any changes to participants quality of life when taking PTC596. The goals of the surgical part are: - Learn if PTC596 is able to reach the tumor in the brain; - Learn what kind of side effects can be caused by PTC596 with radiation therapy; - Learn more about the pharmacology of PTC596; - Learn more about the biological effects of PTC596 on the cells in their body including any changes to the tumor DNA; - Determine whether PTC596 with radiation therapy is a beneficial treatment for their tumor; - Determine if there are any changes to their quality of life when taking PTC596. Funding Source - FDA OOPD
    Location: 4 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

  • Genetically Engineered Cells (C7R-GD2.CAR T Cells) for the Treatment of Patients with GD2-Expressing High Grade Glioma or Diffuse Intrinsic Pontine Glioma, The GAIL-B Trial

    This phase I trial evaluates the best dose and possible benefits and / or side effects of C7R-GD2.CAR T cells in treating patients with GD2-expressing high grade glioma or diffuse intrinsic pontine glioma. GD2 is a protein found on almost all high grade glioma / diffuse intrinsic pontine glioma cells. Another purpose is to find out how long these cells can be detected in the blood. This trial 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. Previous studies suggest that putting a new antibody gene into T cells may make them recognize tumor cells and kill them. In this trial, the C7R-GD2.CAR T cells are grown in the laboratory by infecting T cells with a retroviral vector (a special virus that can carry a new gene into cells) containing one gene that can recognize and kill tumor cells (GD2.CAR) and another gene called C7R that may help these cells survive longer. Giving C7R-GD2.CAR T cells with standard of care chemotherapy may allow the T cells to expand and stay longer in the body, potentially killing tumor cells more effectively.
    Location: 2 locations

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

  • H3.3K27M-specific Peptide Vaccine and Poly ICLC with or without Nivolumab in Treating Patients with Newly Diagnosed HLA-A2 Positive, H3.3K27M Positive Diffuse Intrinsic Pontine Glioma or Other Newly Diagnosed Gliomas

    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. Nivolumab is designed to target a specific marker on cancer cells. It is believed that when the marker is targeted, the immune system works better to attack tumor cells. Giving H3.3K27M-specific peptide vaccine and poly ICLC with or without nivolumab may work better at treating HLA-A2 positive, H3.3K27M positive glioma.
    Location: 17 locations

  • 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: 2 locations

  • A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)

    This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will enroll patients requiring a biopsy in order to assess BXQ-350 concentrations in the biopsied tumor.
    Location: 2 locations

  • WP1066 for the Treatment of Recurrent or Refractory and Progressive Malignant Brain Tumors

    This phase I trial identifies the side effects and best dose of WP1066 in treating patients with cancerous (malignant) brain tumors that have come back (recurrent) or have not responded to treatment (refractory), and are growing, spreading, or getting worse (progressive). WP1066 is designed to target the STAT3 pathway in tumor cells, which makes these cells divide, increases new blood vessels to the tumor, causes the tumor cells to move throughout the body and brain, and avoids them being detected by the immune system. Targeting this pathway may cause the immune system to kill the tumor cells. Giving WP1066 may help to control the disease.
    Location: Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia

  • Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG

    Indoximod was developed to inhibit the IDO (indoleamine 2,3-dioxygenase) enzymatic pathway, which is important in the natural regulation of immune responses. This potent immune suppressive mechanism has been implicated in regulating immune responses in settings as diverse as infection, tissue / organ transplant, autoimmunity, and cancer. By inhibiting the IDO pathway, we hypothesize that indoximod will improve antitumor immune responses and thereby slow the growth of tumors. The central clinical hypothesis for the GCC1949 study is that inhibiting the pivotal IDO pathway by adding indoximod immunotherapy during chemotherapy and / or radiation is a potent approach for breaking immune tolerance to pediatric tumors that will improve outcomes, relative to standard therapy alone. This is an NCI-funded (R01 CA229646, MPI: Johnson and Munn) open-label phase 2 trial using indoximod-based combination chemo-radio-immunotherapy for treatment of patients age 3 to 21 years who have progressive brain cancer (glioblastoma, medulloblastoma, or ependymoma), or newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Statistical analysis will stratify patients based on whether their treatment plan includes up-front radiation (or proton) therapy in combination with indoximod. Central review of tissue diagnosis from prior surgery is required, except non-biopsied DIPG. This study will use the "immune-adapted Response Assessment for Neuro-Oncology" (iRANO) criteria for measurement of outcomes. Planned enrollment is up to 140 patients.
    Location: 2 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

  • Convection-Enhanced Delivery of MTX110 and Gadolinium for the Treatment of Diffuse Midline Glioma

    This phase I trial investigates the side effects and best dose of MXT110 when given together with gadolinium via convection-enhanced delivery (CED) in treating patients with diffuse midline glioma. MXT110 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Gadolinium is a contrast agent that helps show abnormal areas inside the body. CED is a method of delivering drugs directly to the tumor, and is being used because the natural barrier of the brain does not allow drugs to successfully reach the tumor in sufficient amounts to treat cancer. Using CED bypasses this natural barrier of the brain and may treat the tumor more effectively in patients with diffuse midline glioma.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • GD2CART for the Treatment of H3K27M Mutated Diffuse Intrinsic Pontine Glioma or Spinal Diffuse Midline Glioma

    This phase I trial investigates the side effects and best dose of autologous GD2 chimeric antigen receptor (CAR) T cells (GD2CART) and how well it works in treating patients with diffuse intrinsic pontine glioma or spinal diffuse midline glioma. The chimeric antigen receptor (CAR) is a genetically-engineered receptor made so that immune cells can recognize and respond to a specific molecule, which in this trial is the GD2 protein. This uses a portion of an antibody to GD2 and part of a molecule that activates or ‘turns on’ the immune cell. The CAR molecule is combined with a patient's T cells, to help the T cells find cancer in the body. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, are given before GD2CART to help prepare the immune system to accept GD2CART, and may help let the GD2CART grow in the body and attack cancer cells. The purpose of this trial is to test the safety of giving GD2CART to children and young adults with diffuse intrinsic pontine glioma or diffuse midline glioma, and determine its effects, both good and bad, and to test how the cancer responds to GD2CART after chemotherapy.
    Location: Lucile Packard Children's Hospital Stanford University, Palo Alto, California

  • Genetically Engineered Cells (B7-H3-specific CAR T Cells) in Treating Pediatric Patients with Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, or Recurrent or Refractory Central Nervous System Tumors

    This phase I trial studies the side effects and best dose of genetically engineered cells (B7-H3-specific CAR T cells) and how well it works in treating patients with diffuse intrinsic pontine glioma, diffuse midline glioma, or central nervous system tumors that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with B7-H3-specific CAR T cells may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • PLX3397 in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN)

    Background: - Some people with cancer have solid tumors. Others have refractory leukemia. This doesn t go away after treatment. Researchers want to see if a drug called PLX3397 can shrink tumors or stop them from growing. Objectives: - To find the highest safe dose and side effects of PLX3397. To see if it helps treat certain types of cancer. Eligibility: - People ages 3 22 with a solid tumor or leukemia that has returned or not responded to cancer therapies. - For Phase II, people ages 3 31 with a Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibroma (PN) that cannot be removed with surgery. Design: - Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Heart tests - Scans or other tests of the tumor - Participants will take PLX3397 as a capsule once daily for a 28-day cycle. They can do this for up to 2 years. - During the study, participants will have many tests and procedures. They include repeats of the screening tests. Participants will keep a diary of symptoms. - Participants with solid tumors will have scans or x-rays. - Participants with NF1 PN will have MRI scans. - Participants with leukemia will have blood tests. They may have a bone marrow sample taken. - Some participants may have a biopsy. - When finished taking PLX3397, participants will have follow-up visits. They will repeat the screening tests and note side effects. - Phase II will follow the same procedures as Phase I above, but participants will also fill out questionnaires about their pain and quality of life.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Iodine I 124 Monoclonal Antibody 8H9 in Treating Patients with Non-Progressive Diffuse Pontine Gliomas Previously Treated with External Beam Radiation Therapy

    This phase I trial studies the side effects and the best dose of iodine I 124 monoclonal antibody 8H9 in treating patients with non-progressive diffuse pontine gliomas previously treated with external beam radiation therapy. Radiolabeled monoclonal antibodies, such as iodine I 124 monoclonal antibody 8H9, can find tumor cells and carry tumor-killing substances to them without harming normal cells.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York


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