Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor

Phase 1

Completed

• Conditions: Anaplastic Oligodendroglioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligoastrocytoma
• Interventions: Biological: Toca 511 vector; Drug: Toca FC

• Registration Number: NCT01470794
• Lead Sponsor: Tocagen Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Study Start: 2012-02
• Primary Completion: 2016-04-12
• Study Completion: 2016-04-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Toca FC	Toca 511 vector/Toca FC prodrug
Single Arm	Toca 511 vector	Toca 511 vector/Toca FC prodrug

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	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/Toca FC combination.

Secondary Outcome Measures

Name	Time	Method
Overall Survival of Subjects	Overall survival, Overall survival at 6 months (OS6), 9 months (OS9), and 12 months (OS12)
Progression Free Survival (PFS) of Subjects	PFS of subjects at 6 months (PFS-6)

Trial Locations

Locations (8)

UCLA; 🇺🇸 Los Angeles, California, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of California at San Diego; 🇺🇸 San Diego, California, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

JFK Medical Center; 🇺🇸 Edison, New Jersey, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Swedish Neuroscience Institute; 🇺🇸 Seattle, Washington, United States