Clinical Trial: Study of a Retroviral Replicating Vector to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A P1 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 T

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 subjects 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, subjects will take an oral course of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during the 31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine, a drug approved by the FDA to treat brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain tumors. After completion of this study, all subjects will be eligible for enrollment and encouraged to be in 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 Summary:
Sponsor: Tocagen Inc.

Current Primary Outcome: Dose Limiting Toxicities [ Time Frame: 2 months ]

Excluding nausea, vomiting and fatigue, any Grade 3 or higher non-hematologic toxicity or any Grade 4 or higher hematologic toxicity, felt to be related to Toca 511 or the Toca 511/5-FC combination.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival of Subjects [ Time Frame: Overall survival, Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12) ]
  • Progression Free Survival (PFS) of Subjects [ Time Frame: PFS of subjects at 6 months (PFS-6) ]


Original Secondary Outcome: PFS-6 [ Time Frame: 6 months ]

The percentage of subjects who have not progressed or died at 6 months.


Information By: Tocagen Inc.

Dates:
Date Received: November 4, 2011
Date Started: January 2012
Date Completion: July 2016
Last Updated: February 23, 2016
Last Verified: February 2016