Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 12, 2016

Study Completion Date

April 12, 2016

Conditions
Glioblastoma MultiformeAnaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic Oligoastrocytoma
Interventions
BIOLOGICAL

Toca 511 vector

All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antifungal 5-FC to the anti-cancer drug 5-FU in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after administration of Toca 511, patients will begin courses of oral Toca FC at pre-specified intervals, depending on cohort, during the approximately 30 week study.

DRUG

Toca FC

Trial Locations (8)

43210

Ohio State University, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48202

Henry Ford Hospital, Detroit

90095

UCLA, Los Angeles

92093

University of California at San Diego, San Diego

98122

Swedish Neuroscience Institute, Seattle

08820

JFK Medical Center, Edison

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Tocagen Inc.

INDUSTRY

NCT01470794 - Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor | Biotech Hunter | Biotech Hunter