Use of Optune NovoTTF-200A System in Combination with Temozolomide and Bevacizumab with High Grade Glioma and Ependymoma
A Phase I Trial of the Optune NovoTTF-200A System in Pediatric Patients With High-grade Glioma and Ependymoma
Clinical Trial Information
Trial Contact: El-Shami, Jessica; Leffin, Melissa; Spinelli, Jennifer; Cevallos, Claudia
IRB No: 18.042.03
Protocol Abbrev: HUMC 1612
Principal Investigator: Amy A Smith, MD
Phase: Device: Significant Risk
Age Group: Pediatric
Secondary Protocol No: HUMC 1612
Treatment: Device: Optune NovoTTF-200A System; Drug: Temozolomide; Drug: Bevacizumab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03128047
To determine the safety and tolerability of the Optune NovoTTF-200A
System when used in combination with temozolomide and bevacizumab in pediatric patients with newly-diagnosed and recurrent high-grade gliomas and recurrent ependymomas.
• Age >=5 years and <21 years
• Patients must have a minimum head circumference of 44 cm
• Diagnosis: Patients must have either a histologically- or cytologically-confirmed
supratentorial highgrade glioma or supratentorial ependymoma.
- Patients with metastatic disease involving the infratentorium or spinal cord are eligible providing that they have a supratentorial tumor that is able to be targeted with TTFields.