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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Given PO
Undergo radiation therapy
Undergo tumor treatment fields therapy using NovoTTF-200A device
Undergo tumor treatment fields therapy using NovoTTF-200A device
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
NovoTTF-200A device discontinuation rate due to skin toxicity
Discontinuation events are defined as the discontinuation of NovoTTF-200A device for \> 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.
Time frame: Up to 30 days after finishing chemoradiation treatment
Progression-free survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year
Overall survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year
Event-free survival
Will be evaluated using the Kaplan-Meier method.
Time frame: From enrollment up to 1 year
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