NCT04397679

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Treatment of Adults with Newly Diagnosed Glioblastoma with Partial Brain Radiation Therapy Plus Temozolomide and Chloroquine Followed by Tumor Treating Fields Plus Temozolomide and Chloroquine -- a Pilot Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 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.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy	Undergo 3D CRT
RADIATION	Intensity-Modulated Radiation Therapy (IMRT)	Undergo IMRT
DRUG	Temozolomide	Given PO
DRUG	Chloroquine	Given PO
PROCEDURE	Tumor Treating Fields Therapy (TTF)	Undergo TTF

Timeline

• Start date: 2021-08-12
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2020-05-21
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study