This study focuses on patients with recurrent high grade glioma whose tumor recurrence is still relatively small (≤ 9 cm2 in its greatest cross sectional area). Because these tumors may grow rapidly, patients are encouraged to discuss this study with their doctor as soon as a recurrence becomes apparent.
The study is conducted in two parts. Part one is studying increasing single intratumoral doses of Toca 511 delivered into the tumor through a small hole in the skull. Approximately 4 weeks after injection of Toca 511 subjects begin a course of oral Toca FC. If tolerated, these courses of Toca FC will be repeated. The major focus of part one of this study is to identify the highest safe and tolerated dose of Toca 511. Gadolinium-enhanced MRI scans will be performed to assess changes in tumor size.
In part two of the study, the highest safe and tolerated dose of Toca 511 identified in part one of the study will be administered to nine more subjects. This part of the study will focus on safety as well as tumor response as assessed by gadolinium-enhanced MRI scans.
A patient may qualify for this study if the patient:
- Has a recurrent high grade glioma (Grade 3 or Grade 4)
- Has had prior surgery, radiation and chemotherapy
- Is at least 18 years of age