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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

  • Objective

    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.

  • Key Eligibility

    •   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.