Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ependymoma
- Malignant Glioma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 21 years
- Gender
- Both males and females
Description
Primary Objectives: I To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. II To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progr...
Primary Objectives: I To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. II To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. Secondary Objectives: I To estimate the response rate and Event-Free Survival (EFS) as markers of anti-tumor activity of the Optune device within the context of a feasibility trial. II To assess the association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study. III To explore the impact of the Optune device on the children and families undergoing this therapy, and to explore the association between demographic (e.g., SES, gender), disease (e.g., risk status), treatment, and behavioral variables with health-related quality of life (QoL) changes. IV To explore the association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS. Outline: The Optune will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles. The patients will be followed up for 30 days after the last application of the Optune device.
Tracking Information
- NCT #
- NCT03033992
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Stewart Goldman, MD Ann & Robert H. Lurie Children Hospital of Chicago
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