P2/3 Randomized Study of Toca 511 & Toca FC Versus SOC in Subjects Undergoing Surgery for Recurrent GBM/AA (Toca5)
Biological: Toca 511
Drug: Toca FC
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma|
- Compare overall survival between two arms (requires 116 events) [ Time Frame: 21 months from first patient randomized ] [ Designated as safety issue: No ]
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: Toca 511/Toca FC
Resection followed by administration of up to 4 mL Toca 511 (vocimagene amiretrorepvec). Toca 511 is administered by injection into the wall of the subject's tumor resection cavity on Day 1 (up to 40 injections of 0.1 mL)
Toca FC is an extended-release formulation of flucytosine. Toca FC will be administered at 220 mg/kg/day orally for 7-day courses beginning at least 6 weeks after resection and repeated approximately every 6 weeks.
Biological: Toca 511
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector.
Other Names:Drug: Toca FC
Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with "TOCA FC" embossed on one side and "500" embossed on the other side
Active Comparator: Lomustine, temozolomide, or bevacizumab
Investigator selects one of the following:
Bevacizumab: Beginning 6 weeks after tumor resection, bevacizumab will be administered by IV infusion at 10 mg/kg and repeated every 2 weeks. Refer to the prescribing information and to institutional guidelines for details on the administration procedure.
Lomustine: Beginning 6 weeks after tumor resection, lomustine will be administered as a single oral dose of 110 mg/m2 and repeated every 6 weeks. Refer to the prescribing information and to institutional guidelines for details regarding the administration procedure.
Temozolomide: Beginning 6 weeks after tumor resection, temozolomide will be administered per 1 of 2 options:
Other Names:Drug: Temozolomide
Other Name: TemodarBiological: Bevacizumab
Other Name: Avastin
Please refer to this study by its ClinicalTrials.gov identifier: NCT02414165
|Contact: Asha Das, MDfirstname.lastname@example.org|
|Contact: Mary Lovely, PhD, RNemail@example.com|
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|Principal Investigator:||Timothy Cloughesy, MD||University of California, Los Angeles|