Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma
NCT03452930 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-06-04
Summary
This phase I trial studies the side effects and best dose of tinostamustine (EDO-S101) given with or without radiation therapy in treating patients with newly diagnosed MGMT-unmethylated glioblastoma. Tinostamustine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in patients with glioblastoma.
Conditions
- Glioblastoma
- Gliosarcoma
- MGMT-Unmethylated Glioblastoma
Interventions
- RADIATION
-
Radiation Therapy
Undergo RT
- DRUG
-
Tinostamustine
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Shiao-Pei S Weathers · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-13
- Primary Completion
- 2024-06-05
- Completion
- 2024-06-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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