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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 August 23, 2015
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:
Asha Das, MD, Phone: 858-822-6575, Email: adas@tocagen.com

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 subjects 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, subjects will take an oral course of 5-FC, an antifungal antibiotic. These one week courses of 5-FC will be repeated during the 31 week study. In some subjects, Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine, a drug approved by the FDA to treat brain tumors or bevacizumab, an alternative drug approved by the FDA to treat brain tumors. After completion of this study, all subjects will be eligible for enrollment and encouraged to be in 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.

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:

Overall Survival of Subjects

Progression Free Survival (PFS) of Subjects

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 years old and 80 years old inclusive?

- Has the subject had histologically proven HGG with recurrence or progression

following initial definitive therapy(s) such as surgery with or without adjuvant radiation therapy and/or chemotherapy (confirmed by diagnostic biopsy or contrast-enhanced MRI and evaluable by Macdonald criteria)? Note if first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.

- Does the subject have a single, HGG tumor recurrence/progression that is ≤ 5 cm in

its greatest dimension?

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

candidate for ≥ 80% resection?

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

- Does the subject have a Karnofsky performance status ≥ 70?

- Does the subject have an absolute neutrophil count (ANC) ≥ 1500/mm3?

- Does the subject have an absolute lymphocyte count ≥ 500/mm3?

- Does the subject have a platelet count ≥ 100,000/mm3?

- Does the subject have a Hgb ≥ 10 g/dL?

- Does the subject have a normal PT/PTT? (subnormal PT/PTT acceptable)

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

(inclusive) by the Cockcroft-Gault formula?

- Does the subject have an ALT < 3 times the upper limit of the laboratory reference

range and 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?

- Is the subject willing to use condoms for contraception for 6 months after receiving

Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer. If the subject is a fertile female, is she willing to use contraception for at least 12 months?

- 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 any infection

requiring antibiotic, antifungal or antiviral therapy?

- Has the subject had a surgical procedure in the last 28 days or a surgical wound that

is not healed?

- 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 or her from

being 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, or

within the past 5 weeks?

- Does the patient have a history of prior malignancy, excluding basal or squamous cell

carcinoma of the skin, with an expected survival of less than five years?

Locations and Contacts

Asha Das, MD, Phone: 858-822-6575, Email: adas@tocagen.com

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Not yet recruiting
Cindy Atkins, Phone: 205-975-0277, Email: ciatkins@uabmc.edu
James M Markert, M.D., Phone: 205-934-4011, Email: jmarkert@uabmc.edu

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: June 25, 2015

Page last updated: August 23, 2015

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