The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule. The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months. Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
Patients will be given temozolomide according to routine treatment dosing and schedule.
Patients will be given radiation therapy according to routine treatment dosing and schedule.
University of California San Francisco
San Francisco, California, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy
Number of patients who experienced a treatment-related adverse event
Time frame: 15 Weeks (8 weeks after completion of trimodal therapy)
Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy
Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
Time frame: 15 weeks (8 weeks after completion of trimodal therapy)
Overall Survival Rate
Number of patients alive at Day 106 (15 weeks), end of main study period
Time frame: Day 106
Progression-free Survival at 6 Months and 24 Months
Number of patients who are progression free at 6 months and 24 months. Progression is defined as any of the following: greater than or equal to 25% increase in sum of lesions compared with smallest tumor measurement obtained, significant increase in T2/FLAIR non-enhancing lesions, any new lesion, clear clinical deterioration not attributable to other causes, or clear progression of non-measureable disease.
Time frame: 6 months and 24 months
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