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

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

Official Title: A P1 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

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. Subjects meeting all of the inclusion and none of the exclusion criteria will receive a portion of the total dose of Toca 511 administered as an intravenous, bolus injection, followed approximately 11 days later by the remainder of the dose injected into the walls of the resection cavity at the time of planned tumor resection. Approximately 6 weeks later, subjects will begin treatment with oral Toca FC taken every 8 hours for 7 days, and repeated every 4 weeks. All subjects enrolled in this study will be encouraged to participate in a continuation protocol that enables additional 5-FC administration and the collection of long-term safety and response data.

Detailed Summary:
Sponsor: Tocagen Inc.

Current Primary Outcome: Determine maximum feasible, safe, and tolerated dose of Toca 511 as measured by dose limiting toxicities. [ Time Frame: 32 weeks ]

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

Excluding nausea, vomiting, weakness, 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.


Current Secondary Outcome:

  • Measure Toca 511 deposition in tumor at the time of resection by QT-PCR [ Time Frame: At time of surgical resection ]
  • Measure how long Toca 511 stays in blood after IV administration by serum QT-PCR [ Time Frame: 10 days ]
  • Safety and tolerability of Toca FC given at various doses and schedules as measured by dose limiting toxicities. [ Time Frame: 32 weeks ]
  • Evaluate preliminary efficacy of Toca 511 and Toca FC by assessing overall survival, and tumor response rates. [ Time Frame: Ongoing ]


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 8, 2013
Date Started: October 2013
Date Completion: July 2016
Last Updated: February 23, 2016
Last Verified: February 2016