Clinical trials: Diffuse Midline Glioma
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, Diffuse Intrinsic Pontine Glioma
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
The 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.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma
- Trial name
- NCT06333899
- Testing
- Lorlatinib, Lorlatinib with chemotherapy1, Lorlatinib with chemotherapy 2
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Glioma of Spinal Cord, Glioma of Brainstem
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
The primary purpose of this study is to test whether CAR T cells targeting GD2 (GD2CART) can be successfully made and safely given to children and adults with H3K27M-mutant diffuse midline glioma (DMG).
- Trial name
- NCT04196413
- Testing
- GD2 CAR T cells, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- Stanford University
Pediatric Brain Stem Glioma
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status.
- Trial name
- NCT01878266
- Testing
- Hypofractionated Arm (1), Hypofractionated Arm (2), Conventional Arm (3)
- Where
- Egypt
- Volunteers
- 119 people
- Sponsor
- Children's Cancer Hospital Egypt 57357
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
A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas.
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of…
- Trial name
- BABY-PULSAR (NCT07918105)
- Testing
- Pulsed Low-Dose-Rate Radiotherapy, pLDRT
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
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
Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
The purpose of this study is to assess the feasibility, safety and efficacy of H3K27M-specific engineered immune effector (EIE) therapy in patients with high-risk, H3K27M-positive diffuse midline glioma/diffuse intrinsic pontine…
- Trial name
- NCT07501156
- Testing
- H3K27M-EIEs
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen Geno-Immune Medical Institute
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 Gliomas (DIPG)
IMPT Versus IMRT for Diffuse Intrinsic Pontine Glioma
This is a prospective, open-label, multicenter, phase III randomized controlled trial comparing intensity-modulated proton therapy (IMPT) with intensity-modulated radiation therapy (IMRT) in participants aged 3-18 years with…
- Trial name
- NCT07869524
- Testing
- Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT)
- Where
- China
- Volunteers
- 142 people
- Sponsor
- Shandong Cancer Hospital and Institute
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
Diffuse Midline Glioma, H3 K27-Altered, Metastatic Malignant Neoplasm in the Central Nervous System
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does…
- Conditions
- Diffuse Midline Glioma, H3 K27-Altered, Metastatic Malignant Neoplasm in the Central Nervous System, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Diffuse Midline Glioma, H3 K27-Altered
- Trial name
- NCT04870944
- Testing
- Biospecimen Collection, Bone Marrow Aspirate, Bone Marrow Biopsy
- Where
- 35 sites in United States, Australia
- Volunteers
- 63 people
- Sponsor
- Children's Oncology Group
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
Diffuse Midline Glioma, Diffuse Midline High-grade Glioma
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
This is a multisite, phase I/II clinical trial in children and young adults with newly-diagnosed high-grade glioma (HGG), diffuse midline glioma (DMG) and recurrent HGG/DMG, Medulloblastoma (MB), or ependymoma (EPN) to determine…
- Conditions
- Diffuse Midline Glioma, Diffuse Midline High-grade Glioma, Medulloblastoma, Ependymoma
- Trial name
- PRiME II (NCT06639607)
- Testing
- PEP-CMV vaccine, Tetanus booster, Nivolumab
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Washington University School of Medicine
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
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 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