Clinical trials: Diffuse Gliomas
Diffuse Astrocytoma, Anaplastic Astrocytoma
Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT03975829
- Testing
- dabrafenib, trametinib
- Where
- 54 sites in United States, Argentina and 17 more
- Volunteers
- 163 people
- Sponsor
- Novartis Pharmaceuticals
Glioblastoma, Adult-type Diffuse Gliomas
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating…
- Trial name
- FIGHT-209 (NCT05267106)
- Testing
- Pemigatinib
- Where
- 79 sites in United States, Denmark and 7 more
- Volunteers
- 83 people
- Sponsor
- Incyte Corporation
Diffuse Intrinsic Brainstem Gliomas
Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma
The study consists in only one treatment group, which will receive the first-line therapy for the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product (nimotuzumab)
- Trial name
- POLARIS (NCT01145170)
- Testing
- Radiotherapy, Nimotuzumab
- Where
- 5 sites in Brazil, Cuba
- Volunteers
- 40 people
- Sponsor
- Eurofarma Laboratorios S.A.
DIPG
131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma
Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site.
- Trial name
- NCT05063357
- Testing
- 131I-Omburtamab, Convention Enhanced Delivery
- Sponsor
- Y-mAbs Therapeutics
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 Glioma (III or IV), Diffuse Midline Glioma (DMG)
A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)
An Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with HGG, especially in DMG and other Recurrent HGG.
- Conditions
- High Grade Glioma (III or IV), Diffuse Midline Glioma (DMG), Glioblastoma (GBM)
- Trial name
- NCT07455045
- Testing
- FZ-AD005
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Ewing Sarcoma, Solid Tumors
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults…
- Conditions
- Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma
- Trial name
- NCT03709680
- Testing
- Palbociclib, Temozolomide, Irinotecan
- Where
- 84 sites in United States, Brazil and 11 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
Oncology, DIPG
xPedite: A Study to Expedite DIPG and DMG Research
This study will gather data from new and existing patients with patient medical records, and patient/family/caregiver reported information to establish a clear natural history of disease suitable to serve as an external…
- Conditions
- Oncology, DIPG, DMG
- Trial name
- NCT06140719
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- xCures
Relapsed Solid Tumor, Refractory Solid Tumor
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…
- Conditions
- Relapsed Solid Tumor, Refractory Solid Tumor, Relapsed Central Nervous System Tumor, Refractory Central Nervous System Tumor
- Trial name
- NCT03690869
- Testing
- cemiplimab (monotherapy), cemiplimab (maintenance), Conventional or hypofractionated
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Regeneron Pharmaceuticals
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 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.
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
Refractory Cancer, Refractory Neoplasm
9-ING-41 in Pediatric Patients With Refractory Malignancies.
9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult patients. This Phase 1 study will study its efficacy in paediatric patients with advanced malignancies.
- Conditions
- Refractory Cancer, Refractory Neoplasm, Cancer Pediatric, Refractory Tumor
- Trial name
- NCT04239092
- Testing
- 9-ING-41, Irinotecan, Temozolomide
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Actuate Therapeutics Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
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.
Recurrent Diffuse Pontine Gliomas
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG)…
- Trial name
- NCT00600054
- Testing
- nimotuzumab (anti EGFR humanized monoclonal antibody)
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 44 people
- Sponsor
- YM BioSciences
Brain and Central Nervous System Tumors, Breast Cancer
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Breast Cancer, Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Trial name
- NCT00006368
- Testing
- yttrium Y 90-edotreotide
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Pediatric Brain Tumor, Diffuse Intrinsic Pontine Glioma
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…
- Trial name
- NCT03330197
- Testing
- Ad-RTS-hIL-12, Oral Veledimex - Arm 1 (Pediatric Brain Tumor), Oral Veledimex - Arm 2 (DIPG)
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Alaunos Therapeutics