Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511
IRB TOG1311
CC CC00195
Hospital Main Campus
Stage N/A
Phase Phase 2
Disease Brain
Drug Flucytosine (5-FC)
Description
Primary Objective- To allow for extended safety observations as required by the guidelines for patients enrolled in gene transfer studies.
- Efficacy for subjects will be reported in the parent study.
- To assess safety and preliminary efficacy of Toca 511 when reinjected in selected subjects followed by treatment with Toca FC.
Inclusion Criteria
- Has the subject given written informed consent?
- Has the subject received Toca 511 in a prior study?
- Is the subject willing and able to abide by the protocol?
Exclusion Criteria
- If the subject elects to continue with Toca FC, does the subject have a history of allergy or intolerance to flucytosine?
