Clinical trials: Diffuse Midline Glioma, H3 K27M-Mutant
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 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
Pediatric Tumor of CNS, Pediatric Tumor of Brain
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas.
- Conditions
- Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem
- Trial name
- NCT06357377
- Testing
- NEO100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neonc Technologies, Inc.
Glioblastoma, High-Grade Glioma (WHO III-IV)
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
This is an open label, intra-patient dose escalation, to evaluate ADI-PEG 20, in combination with Temozolomide (TMZ) and radiation therapy (RT) in children, adolescents and young adult patients with newly diagnosed high grade…
- Conditions
- Glioblastoma, High-Grade Glioma (WHO III-IV), High-grade Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- NCT07389278
- Testing
- ADI-PEG 20 (Arginine deiminase pegylated), Temozolomide (TMZ), Standard of Care Radiation Therapy (RT)
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- Sabine Mueller, MD, PhD
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
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 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
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 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
Central Nervous System Neoplasms, Atypical Teratoid/Rhabdoid Tumor
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
Loc3CAR is a Phase I clinical trial evaluating the use of autologous B7-H3-CAR T cells for participants ≤ 21 years old with primary CNS neoplasms.
- Conditions
- Central Nervous System Neoplasms, Atypical Teratoid/Rhabdoid Tumor, Diffuse Midline Glioma, H3 K27M-Mutant, Ependymoma
- Trial name
- NCT05835687
- Testing
- B7-H3-CAR T cells
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- St. Jude Children's Research Hospital
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
Combination Therapy for the Treatment of Diffuse Midline Gliomas
This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs).
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- PNOC022 (NCT05009992)
- Testing
- ONC201, Radiation Therapy, Paxalisib
- Where
- 32 sites in United States, Australia and 4 more
- Volunteers
- 360 people
- Sponsor
- University of California, San Francisco
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 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
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
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
Diffuse Intrinsic Pontine Glioma, Diffuse Pontine and Thalamic Gliomas
Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (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…
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Pontine and Thalamic Gliomas, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- NCT04804709
- Testing
- Panobinostat 15 MG, Focused Ultrasound with neuro-navigator-controlled sonication
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Columbia University
Diffuse Intrinsic Pontine Glioma, Glioma
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
This is 3-arm, multicenter study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC). This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the Histone…
- Conditions
- Diffuse Intrinsic Pontine Glioma, Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- NCT02960230
- Testing
- K27M peptide, Nivolumab
- Where
- 15 sites in United States, Switzerland
- Volunteers
- 50 people
- Sponsor
- Sabine Mueller, MD, PhD
Cancer, Solid Tumor
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
- Conditions
- Cancer, Solid Tumor, Solid Carcinoma, Advanced Cancer
- Trial name
- NCT05500508
- Testing
- AMXT1501, DFMO
- Where
- 7 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Aminex Therapeutics, Inc.
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.