The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma (Toca5)
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|ClinicalTrials.gov Identifier: NCT02414165|
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : March 6, 2018
This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process.
Funding Source - FDA OOPD
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Anaplastic Astrocytoma||Biological: Toca 511 Drug: Toca FC Drug: Lomustine Drug: Temozolomide Biological: Bevacizumab||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2023|
Experimental: Toca 511/Toca FC
Resection followed by administration of 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 (approximately 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 and is supplied as 500 mg tablets
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
- To compare the overall survival (OS) of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection for recurrence of glioblastoma or anaplastic astrocytoma [ Time Frame: 30 December 2019 ]Time from randomization date to death due to any cause
- Durable Response Rate (CR or PR ≥ 24 weeks) [ Time Frame: 30 December 2019 ]The proportion of patients whose best response is either CR or PR lasting at least 24 weeks, according to modified RANO criteria
- Durable Clinical Benefit Rate (CR or PR ≥ 24 weeks or SD ≥ 18 months) [ Time Frame: 30 December 2019 ]The proportion of subjects whose best overall response is either CR or PR lasting at least 24 weeks, or stable disease (SD) lasting at least 18 months, according to modified RANO criteria
- Duration of Durable Response [ Time Frame: 30 December 2019 ]Time from documentation of durable response to disease progression or death due to disease progression
- Overall Survival at 12 months [ Time Frame: 30 December 2019 ]Time from randomization date to death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414165
|Contact: Asha Das, MDemail@example.com|
|Contact: Mary Lovely, PhD, RNfirstname.lastname@example.org|
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|Principal Investigator:||Timothy Cloughesy, MD||University of California, Los Angeles|