Clinical trials: Diffuse Midline Glioma
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
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
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
Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4)
A Study of 177Lu-PSMA-617 in People With Gliomas
The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.
- Conditions
- Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype, Diffuse Midline Glioma, H3 K27-Altered
- Trial name
- NCT07223034
- Testing
- Temozolomide, 177Lu-PSMA-617, 68Ga-PSMA-PET scan/ MRI
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG
The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2…
- Trial name
- NCT05123534
- Testing
- SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- SonALAsense, Inc.
High Grade Gliomas, Atypical Teratoid Rhabdoid Tumors (ATRT)
Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor
In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe…
- Conditions
- High Grade Gliomas, Atypical Teratoid Rhabdoid Tumors (ATRT), Diffuse Midline Glioma, DIPG
- Trial name
- GABRIEL (NCT07331064)
- Testing
- Gallium maltolate
- Volunteers
- 15 people
- Sponsor
- Sarah Rumler
Brain Tumor, Pediatric, Medulloblastoma, Childhood
GD2-CAR T Cells for Pediatric Brain Tumours
The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory…
- Conditions
- Brain Tumor, Pediatric, Medulloblastoma, Childhood, Embryonal Tumor, High Grade Glioma
- Trial name
- NCT05298995
- Testing
- GD2-CART01 (iC9-GD2-CAR T-cells)
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
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
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, H3 K27-Altered
Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES)
This study is for people (children and adults) with a rare and aggressive brain tumor called H3K27-altered diffuse midline glioma (DMG) located in the pons, a deep part of the brainstem.
- Trial name
- FIDES (NCT07562971)
- Testing
- Focused Ultrasound (FUS) Blood-Brain Barrier Opening, Temozolomide (TMZ)
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- UMC Utrecht
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.
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
Glioblastoma, Diffuse Midline Glioma
Oral ONC201 in Adult Recurrent Glioblastoma
This was a Phase 2, open-label, 6-arm, multi-center study of dordaviprone (ONC201) in patients with recurrent glioblastoma (Arms A, B, and C), H3 K27M-mutant diffuse glioma (Arm D), or diffuse midline glioma (Arms E and F).
- Conditions
- Glioblastoma, Diffuse Midline Glioma, H3 K27M Glioma, Thalamic Glioma
- Trial name
- NCT02525692
- Testing
- Dordaviprone (ONC201)
- Where
- 5 sites in United States
- Volunteers
- 84 people
- Sponsor
- Jazz Pharmaceuticals
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
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 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
Solid Tumors
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with…
- Trial name
- NCT02711137
- Testing
- INCB057643, Gemcitabine, Paclitaxel
- Where
- 18 sites in United States, Belgium and 1 more
- Volunteers
- 137 people
- Sponsor
- Incyte Corporation
Glioblastoma (GBM), Diffuse Midline Glioma (DMG)
Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
This is a single-arm open-label phase 1 dose escalation/expansion trial assessing the safety and efficacy of concurrent intrathecal azacitidine and intrathecal nivolumab in recurrent high-grade glioma.
- Conditions
- Glioblastoma (GBM), Diffuse Midline Glioma (DMG), Astrocytoma, IDH-Mutant, Grade 4, Diffuse Hemispheric Glioma, H3 G34-Mutant
- Trial name
- NCT06896110
- Testing
- Nivolumab, Azacitidine (AZA), lumbar puncture
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Andrew P. Groves
Glioblastoma (GBM), DIPG
Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma
The standard therapy of glioblastoma (GBM) consists of gross total resection followed by focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ).
- Conditions
- Glioblastoma (GBM), DIPG, Brainstem Glioma, Pediatric, Diffuse Spinal Glioma
- Trial name
- NCT02758366
- Testing
- Doxorubicin
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Meyer Children's Hospital IRCCS
Diffuse Midline Glioma (DMG), Diffuse Intrinsic Pontine Glioma (DIPG)
Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response
Open-label, dose-escalating, Phase 1/2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic…
- Conditions
- Diffuse Midline Glioma (DMG), Diffuse Intrinsic Pontine Glioma (DIPG), Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
- Trial name
- TIGER-1 (NCT07767110)
- Testing
- LSAM-Cisplatin
- Volunteers
- 20 people
- Sponsor
- NanOlogy, LLC