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Brief Title: Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor
Official Title: A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for Recurrent HGG & Followed by Treatment With Extended-Release 5-FC
Study ID: NCT01985256
Brief Summary: This is a multicenter study evaluating the safety and tolerability of Toca 511 administered intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Patients meeting all of the inclusion and none of the exclusion criteria will receive an initial dose of Toca 511 administered as an intravenous, bolus injection, followed approximately 11 days later by an additional dose injected into the walls of the resection cavity at the time of planned tumor resection. Approximately 6 weeks later, patients will begin treatment with oral Toca FC, an antifungal agent, and repeated every 4 weeks. All patients enrolled in this study will be encouraged to participate in a continuation protocol that enables additional Toca FC administration and the collection of long-term safety and response data.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC Irivine, Irvine, California, United States
UCLA, Los Angeles, California, United States
UC San Diego, Moores Cancer Center, San Diego, California, United States
Henry Ford Hospital, Detroit, Michigan, United States
JFK Medical Center New Jersery, Edison, New Jersey, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Name: Asha Das, MD
Affiliation: Tocagen Inc.
Role: STUDY_DIRECTOR
Name: Steven Kalkanis, MD
Affiliation: Henry Ford Hospital
Role: PRINCIPAL_INVESTIGATOR