Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
Completed · Phase 1
Conditions studied: Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma
In brief
This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine or bevacizumab. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.
Key facts
- Study ID
- NCT01470794
- Run by
- Tocagen Inc.
- People needed
- 58
- Starts
- 2012-02-01
- Expected to finish
- 2016-04-12
- Last updated by the study team
- 2018-05-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA — Los Angeles, California, United States
- University of California at San Diego — San Diego, California, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- JFK Medical Center — Edison, New Jersey, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Swedish Neuroscience Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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