Clinical trials: Diffuse Midline Glioma, H3 K27M-Mutant
Diffuse Midline Glioma, H3 K27M-Mutant
Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma
This phase I, first-in-human trial tests the safety, side effects, and best dose of genetically modified cells called KIND T cells after lymphodepletion (a short dose of chemotherapy) in treating patients who are…
- Trial name
- PNOC018 (NCT05478837)
- Testing
- Cyclophosphamide, Fludarabine, Autologous Anti-H3.3K27M TCR-expressing T-cells
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, San Francisco
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
FUS Etoposide for DMG
The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening…
- Trial name
- NCT05762419
- Testing
- Etoposide; Oral, 50 Mg, Focused ultrasound with neuro-navigator-controlled sonication
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Columbia University
Glioma
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.
- Trial name
- NCT07076498
- Testing
- M032
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- M.D. Anderson Cancer Center
High-grade Glioma, Medulloblastoma
Atovaquone Combined With Radiation in Children With Malignant Brain Tumors
The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade…
- Conditions
- High-grade Glioma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- AflacBT2303 (NCT06624371)
- Testing
- Atovaquone, Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Emory University
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
International Diffuse Intrinsic Pontine Glioma (DIPG)/Diffuse Midline Glioma (DMG) Registry and Repository
Doctors and other medical scientists want learn about the biology of DIPG/DMG and to develop better ways to diagnose and treat patients with DIPG/DMG.
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma
- Trial name
- NCT03101813
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
H3 K27M, Glioma
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following…
- Trial name
- ACTION (NCT05580562)
- Testing
- Dordaviprone (ONC201)
- Where
- 162 sites in United States, Argentina and 16 more
- Volunteers
- 510 people
- Sponsor
- Jazz Pharmaceuticals
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Targeted Pediatric High-Grade Glioma Therapy
The 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.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma
- Trial name
- NCT05839379
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 350 people
- Sponsor
- Nationwide Children's Hospital
Brain and Central Nervous System Tumors
Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas
Pediatric high-grade gliomas are highly aggressive and treatment options are limited. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of GDC-0084 and to estimate its…
- Trial name
- NCT03696355
- Testing
- GDC-0084, radiation therapy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- St. Jude Children's Research Hospital
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
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.
- Trial name
- KONQUER (NCT04771897)
- Testing
- BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance, BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bexion Pharmaceuticals, Inc.
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma…
- Trial name
- NCT05518838
- Testing
- OKN-007
- Where
- 9 sites in United States
- Sponsor
- Oblato, Inc.
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
RE-irradiation of Diffuse MIdline Glioma paTients
The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG).
- Conditions
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors
- Trial name
- REMIT (NCT06093165)
- Testing
- Re-irradiation
- Volunteers
- 59 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma
Adavosertib 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 adavosertib when given together with local radiation therapy in treating children with newly diagnosed diffuse intrinsic pontine gliomas.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- NCT01922076
- Testing
- Adavosertib, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 24 sites in United States, Canada
- Volunteers
- 46 people
- Sponsor
- National Cancer Institute (NCI)
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
The 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…
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma
- Trial name
- NCT05843253
- Testing
- Ribociclib, Everolimus, Temozolomide (TMZ)
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 120 people
- Sponsor
- Nationwide Children's Hospital
Diffuse Midline Glioma, H3 K27M-Mutant, Recurrent High Grade Glioma
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.
- Trial name
- NCT06305910
- Testing
- Treatment with CD200AR-L
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- OX2 Therapeutics
Diffuse Midline Glioma, H3 K27M-Mutant
Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Trial
This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas.
- Trial name
- NCT05077735
- Testing
- Hypofractionated Radiation Therapy, Questionnaire Administration, Magnetic Resonance Imaging
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Diffuse Midline Glioma, H3 K27M-Mutant
CAR T Cells to Target GD2 for DMG
The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma…
- Trial name
- CARMIGO (NCT05544526)
- Testing
- GD2 CAR T cells
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University College, London
Diffuse Midline Glioma (DMG), Glioblastoma
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
This 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…
- Conditions
- Diffuse Midline Glioma (DMG), Glioblastoma, Recurrent Ependymoma, Recurrent Malignant Central Nervous System Neoplasm
- Trial name
- PNOC023 (NCT04732065)
- Testing
- ONC206, Standard of Care Radiation Therapy, Optional Proton (1H) MR spectroscopy (MRS)
- Where
- 7 sites in United States, Netherlands and 1 more
- Volunteers
- 208 people
- Sponsor
- Sabine Mueller, MD, PhD
High Grade Glioma, Astrocytoma
Study of Olutasidenib and Temozolomide in HGG
The 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.
- Conditions
- High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV
- Trial name
- NCT06161974
- Testing
- Olutasidenib + TMZ
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 60 people
- Sponsor
- Rigel Pharmaceuticals
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in…
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-altered
- Trial name
- BIOMEDE 2 (NCT05476939)
- Testing
- Everolimus, ONC201, Radiotherapy
- Where
- 56 sites in Belgium, Denmark and 6 more
- Volunteers
- 433 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB.
- Trial name
- NCT04943848
- Testing
- rHSC-DIPGVax, Balstilimab, Zalifrelimab
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago