NCT03477110

Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity of combination chemoradiotherapy with NovoTTF-200A device (Optune) treatment in newly diagnosed glioblastoma. SECONDARY OBJECTIVES: I. To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune. II. To evaluate the median overall survival, 1-year overall survival, and event-free survival. III. Collect tumor O(6)-Methylguanine-DNA-methyltransferase (MGMT) methylation status and isocitrate dehydrogenase (IDH) mutation status. IV. To evaluate the level of circulating tumor deoxyribonucleic acid (DNA) in glioblastoma patient serum during treatment. V. To evaluate the quality of life of patients treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Given PO
RADIATION	Radiation Therapy	Undergo radiation therapy
DEVICE	NovoTTF-200A Device	Undergo tumor treatment fields therapy using NovoTTF-200A device
PROCEDURE	Tumor Treating Fields Therapy	Undergo tumor treatment fields therapy using NovoTTF-200A device

Timeline

• Start date: 2018-05-04
• Primary completion: 2021-04-21
• Completion: 2024-01-26
• First posted: 2018-03-26
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study