Trials / Completed
CompletedNCT01470794
Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Tocagen Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Glioblastoma Multiforme
- Anaplastic Astrocytoma
- Anaplastic Oligodendroglioma
- Anaplastic Oligoastrocytoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Toca 511 vector | All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antifungal 5-FC to the anti-cancer drug 5-FU in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after administration of Toca 511, patients will begin courses of oral Toca FC at pre-specified intervals, depending on cohort, during the approximately 30 week study. |
| DRUG | Toca FC |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2016-04-12
- Completion
- 2016-04-12
- First posted
- 2011-11-11
- Last updated
- 2018-05-21
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01470794. Inclusion in this directory is not an endorsement.