Study:
A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma
Rationale:
n/a
Purpose:
This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of
increasing, single doses of Toca 511, a Retroviral Replicating Vector (RRV), administered
transcranially to subjects with recurrent high grade glioma (rHGG) who have undergone
surgery, radiation therapy and chemotherapy with temozolomide. Approximately 3-4 weeks
following injection of the RRV, 6-day courses of treatment with oral 5-FC will commence and
will be repeated monthly for up to 6 cycles.
Study Status: Recruiting
Recruiting:
Cathy Brewer, RN 216-444-7937 BrewerC1@ccf.org
| Condition |
Intervention |
Phase |
Glioblastoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma |
Biological: Toca 511 Drug: 5-FC |
Phase 1/Phase 2 |
Verified by
Tocagen Inc.
November, 2012
Sponsored by: Tocagen Inc.
Information provided by: Tocagen Inc.
ClinicalTrials.gov identifier: NCT01156584
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
n/a