Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
NCT03250299 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2024-06-24
Summary
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase (MGMT) promoter unmethylated glioblastoma (GBM). Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with GBM.
Conditions
- Glioblastoma
- MGMT-Unmethylated Glioblastoma
Interventions
- DRUG
-
Microtubule-Targeted Agent BAL101553
Given PO
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
Sponsors & Collaborators
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
collaborator OTHER -
Basilea Pharmaceutica
lead INDUSTRY
Principal Investigators
-
Matthias Holdhoff, MD · National Cancer Institute (NCI)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-15
- Primary Completion
- 2022-06-03
- Completion
- 2022-08-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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