Partial Brain Radiation Therapy, Temozolomide, Chloroquine, and Tumor Treating Fields Therapy for the Treatment of Newly Diagnosed Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma
- Gliosarcoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the safety of partial brain radiation therapy plus temozolomide and chloroquine followed by tumor treating fields (TTFs) plus temozolomide and chloroquine, specifically grade 3 or higher dermatitis within the first 3 months of the adjuvant therapy phase. SECONDARY ...
PRIMARY OBJECTIVE: I. To determine the safety of partial brain radiation therapy plus temozolomide and chloroquine followed by tumor treating fields (TTFs) plus temozolomide and chloroquine, specifically grade 3 or higher dermatitis within the first 3 months of the adjuvant therapy phase. SECONDARY OBJECTIVE: I. To measure treatment effect via advanced magnetic resonance imaging (MRI) and alpha-[11C]methyl-L-tryptophan (AMT)-positron emission tomography (PET). OUTLINE: Patients undergo 30 fractions of 3-dimensional conformal radiation therapy (3D CRT) or intensity-modulated radiation therapy (IMRT) and receive temozolomide orally (PO) and chloroquine PO daily from day 1 for the duration of radiation therapy up to day 49. Treatment continues in the absence of disease progression or unacceptable toxicity. ADJUVANT TREATMENT: Beginning 4 weeks after the last day of radiation therapy, patients receive temozolomide PO once daily (QD) on days 1-5 and chloroquine PO daily on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients demonstrating continued benefit may continue to receive temozolomide and chloroquine for up to 12 cycles. Patients also undergo TTF therapy over 18 hours or longer per day. After completion of study treatment, patients are followed up monthly for 3 months.
Tracking Information
- NCT #
- NCT04397679
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Michael Dominello, M.D. Barbara Ann Karmanos Institute