Physician VersionPatient Version

Protocol No.Principal InvestigatorPhaseAge GroupScopeSecondary Protocol No.Status
OSU-11122Elder, JamesIAdultNationalTg511-1-01Open

Adapted from the National Cancer Institute's Physician Data Query (PDQ®) Cancer Clinical Trials (http://www.cancer.gov/clinicaltrials)

Title

A P1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by Treatment With Toca FC, Extended-Release 5-FC
Study of a Retroviral Replicating Vector to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor

Summary

This is a multicenter study evaluating the safety and tolerability of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6-7 weeks after injection of Toca 511, the patient will take an oral course of 5-FC, an antifungal antibiotic. These courses of 5-FC will be repeated during the 6-month study. MRI scans will be performed approximately every 2 months. Three subjects will be evaluated at up to 5 dose levels of Toca 511. The dose of Toca 511 a patient receives will depend upon the number of previous study participants and how well they have tolerated the study drugs. All patients enrolled in this study will be encouraged to participate in a continuation protocol that enables additional 5-FC administration and the collection of long-term safety and response data.

To view the NCI PDQ information for this trial, click here

To view the clinicaltrials.gov information for this trial, click here

Eligibility

Inclusion Criteria (must all be answered "Yes"):

Exclusion Criteria (must all be answered "No"):

Applicable Disease Sites

Brain and Central Nervous System

Participating Institutions

James Cancer Hospital
OSU Cancer Center
OSU Medical Center

Contact

Jill Brown
Phone:614-293-5554
Email:jill.brown@osumc.edu