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

Information source: Tocagen Inc.
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma

Intervention: Toca 511 (Biological)

Phase: Phase 1

Status: Recruiting

Sponsored by: Tocagen Inc.

Overall contact:
Wayne Saville, MD, Phone: 858-412-8440, Email: wsaville@tocagen.com

Summary

This is a multicenter study evaluating the safety and tolerability of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 5 weeks after injection of Toca 511, the patient will take an oral course of 5-FC, an antifungal antibiotic. These courses of 5-FC will be repeated during the 6-month study. MRI scans will be performed approximately every 2 months. Three subjects will be evaluated at up to 6 dose levels of Toca 511. The dose of Toca 511 a patient receives will depend upon the number of previous study participants and how well they have tolerated the study drugs. All patients 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.

Clinical Details

Official title: A P1 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dose Limiting Toxicities

Secondary outcome: PFS-6

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria (must all be answered "Yes"):

- Has the subject given written informed consent?

- Is the subject between 18 and 80 years old inclusive?

- Has the subject undergone at least one prior surgical gross-total or subtotal tumor

resection and a course of postoperative radiation therapy with concurrent temozolomide?

- Does the subject have a single tumor recurrence/progression that is < or = 6 cm in

its greatest dimension?

- Based on pre-operative evaluation, is the tumor recurrence/progression a candidate

for a resection of at least 80%?

- Has the subject elected not to undergo treatment with the Gliadel wafer?

- Does the subject have a Karnofsky performance status of at least 70%?

- Does the subjet have an absolute neutrophil count of at least 1500/mm^3?

- Does the subject have an absolute lymphocyte count of at least 500/mm^3?

- Does the subject have a platelet count of at least 100,000/mm^3?

- Does the subject have a Hgb of at least 10 g/dL?

- Does the subject have a normal PT/PTT?

- Does the subject have an estimated glomerular filtration rate of at least 50 mL/min

by the Cockcroft-Gault formula?

- Does the subject have an ALT/AST < 3 times the upper limit of the lab reference range

and a total bilirubin < 1. 5 mg/dL?

- If the subject is a female of childbearing potential, has she had a negative serum

pregnancy test within the past 21 days?

- For males and females, is the subject willing to use condoms for contraception for 6

months or until vector is no longer detected, whichever is longer?

- Is the subject willing and able to abide by the protocol?

Exclusion Criteria (must all be answered "No"):

- Has the subject received cytotoxic chemotherapy within the past 3 weeks (6 weeks for

nitrosoureas) of the planned surgery date?

- Does the subject have, or has the subject had, within the past 4 weeks an infection

requiring antibiotic, antifungal or antiviral therapy?

- Does the subject have any bleeding diathesis, or must the subject take any

anticoagulants, or antiplatelet agents, including NSAIDs, that cannot be stopped for surgery?

- Does the subject have a history of allergy or intolerance to flucytosine?

- Is the subject HIV positive?

- Does the subject have any gastrointestinal disease that would prevent him/her from

bing able to ingest or absorb flucytosine?

- Has the subject received any investigational treatment within the past 30 days?

- Is the subject breast feeding?

- Has the subject received Avastin (bevacizumab) for this recurrence/progression,

within the past 5 weeks?

Locations and Contacts

Wayne Saville, MD, Phone: 858-412-8440, Email: wsaville@tocagen.com

UCLA, Los Angeles, California 90095, United States; Recruiting
Tim Cloughesy, MD, Phone: 310-825-5321
Tim Cloughesy, MD, Principal Investigator

University of California at San Diego, San Diego, California 92093, United States; Recruiting
Brad Brown, Phone: 858-822-5377, Email: bdbrown@ucsd.edu
Santosh Kesari, MD
Santosh Kesari, MD, Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
John Gaggin, RN, BSN, Phone: 313-916-3731, Email: jgaggin1@hfhs.org
Tiffany Pearce, Phone: 313-916-1784, Email: tpearce1@hfhs.org
Tom Mikkelsen, MD, Principal Investigator

JFK Medical Center, Edison, New Jersey 08820, United States; Recruiting
Charles Porbeni, MD, Phone: 732-321-7000, Ext: 68897, Email: cporbeni@jfkhealth.org
Joseph Landolfi, DO, Principal Investigator

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Cathy Brewer, RN, Phone: 216-444-7937, Email: brewerc1@ccf.org
Michael Vogelbaum, MD, PhD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Jill Brown, MS, Phone: 614-293-5554, Email: jill.brown@osumc.edu
James Elder, MD, Principal Investigator

Swedish Neuroscience Institute, Seattle, Washington 98122, United States; Active, not recruiting

Additional Information

Starting date: January 2012
Last updated: July 14, 2014

Page last updated: November 27, 2014

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