Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioma

Glioblastoma

Gliosarcoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.

10 mg/kg every 2 weeks intravenously over 30 minutes.

Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks.

TTFields Therapy

Manmeet Ahluwalia, MD, FACP

This phase II trial will investigate the efficacy and safety of the addition of Optune (Tumor Treating Fields \[TTFields\] Therapy) to bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma.

Patients that have recurrent glioblastoma that has progressed on bevacizumab continue to receive bevacizumab with the addition of Tumor Treating Fields Therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.

Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma

Phase II Trial Of Optune® Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma

Number of participants alive at 6 months. Out of the planned 80 eligible patients, if 36 or more were alive at six months then the null hypothesis that the six-month survival rate is 35% or less would be rejected, concluding that the six-month survival is at least 35%. No testing was done due to the small number of participants resulting from early study closure.

Survival time is defined as time from registration the to date of death from any cause or last known follow-up (censored) and was to be estimated by the Kaplan-Meier method. Given the small number of participants due to early study closure, only the number of patients last reported to be alive at time of study termination is reported.

Progression is defined by the Modified Response Assessment in Neuro-Oncology (RANO) Response Criteria. (The precise definition is too long to be included here.) Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up. Progression-free survival rates were to be estimated using the Kaplan-Meier method. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without progression at time of study termination is reported.

Modified Response Assessment in Neuro-Oncology (RANO) Response Criteria was used to define response and progression. (The precise definitions are too long to be included here.) Objective response is defined as complete or partial response. The percentage of participants with objective response was to be estimated using the exact binomial method with accompanying 95% confidence intervals. Given the small number of participants due to early study closure, only the number of patients with objective response is reported.

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. The percentage of participants with grade 3 or higher treatment-related adverse events was to be estimated using the exact binomial method with accompanying 95% confidence intervals.

NovoCure Ltd.

RTOG Foundation, Inc.

Bevacizumab starts on the first day (+/- 1 day) of Tumor Treating Fields (TTFields) therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.

Bevacizumab: 10 mg/kg every 2 weeks intravenously over 30 minutes.

TTFields Therapy: Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks.

Bevacizumab and TTFields Therapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

This study stopped accrual early due to unmet targeted accrual goals with 3 subjects accrued out of 85 planned.

Spots Global Cancer Trial Database for Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial