Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma
NCT04397679 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2025-01-15
Summary
This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chloroquine is normally used to treat strains of malaria and prior preclinical and clinical data suggests that it may increase the efficacy of both radiation and tumor treating fields therapy. Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. The purpose of this study is to determine the safety of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy in patients with gliobastoma
Conditions
- Glioblastoma
- Gliosarcoma
Interventions
- RADIATION
-
3-Dimensional Conformal Radiation Therapy
Undergo 3D CRT
- RADIATION
-
Intensity-Modulated Radiation Therapy (IMRT)
Undergo IMRT
- DRUG
-
Given PO
- DRUG
-
Chloroquine
Given PO
- PROCEDURE
-
Tumor Treating Fields Therapy (TTF)
Undergo TTF
Sponsors & Collaborators
-
Barbara Ann Karmanos Cancer Institute
lead OTHER
Principal Investigators
-
Michael Dominello, M.D. · Barbara Ann Karmanos Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-12
- Primary Completion
- 2024-05-14
- Completion
- 2024-05-14
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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