Spots Global Cancer Trial Database for Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
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Trial Identification
Brief Title: Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
Official Title: A Phase 1 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 ID: NCT01470794
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Asha Das, MD
Affiliation: Tocagen Inc.
Role: STUDY_DIRECTOR
Name: Timothy Cloughesy, MD, NO
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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