A Study of the Safety of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Newly Diagnosed High Grade Glioma Receiving Standard of Care (Toca7)
The Toca 7 Study: A Phase 1b Study of the Safety of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Newly Diagnosed High Grade Glioma Receiving Standard of Care
Researchers are seeking patients with newly diagnosedHigh Grade Glioma to trial a combination therapy with an investigatory drug regimen involving gene therapy, combined with standard chemo or radiation treatment methods. Tocagen’s regimen uses a viral vector to deliver a gene to the tumor cells, infecting them and imparting a gene to produce cytosine deaminase (CD) enzyme, which will convert the second Tocagen medicine to an anti-cancer drug within the actual tumor cells.
This trial aims to assess the safety of two different doses of the drug combo, which will be administered into the tumor site either directly or after a tumor resection (into the walls of the resection cavity). Treatment will occur concurrently with chemoradiation.
- Have presumed newly diagnosed high grade glioma prior to tissue diagnosis or definitive initial surgical resection
- Be a candidate for planned resection of tumor OR have a newly diagnosed HGG accessible by a technically feasible stereotactic trajectory
- Not have any history of other malignancy, unless disease free for at least 5 years
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility and safety of the patient to participate.
- During a scheduled resection of the HGG tumor, the first Tocagen drug will be administered into the walls of the resection cavity.
- If not a candidate for resection, the drug is delivered to the tumor site directly with a stereotactically-guided needle.
- Approximately 4 to 6 weeks after tumor resection, patients begin chemoradiation. At the start of the 2nd and 6th week of chemoradiation and every 28 days thereafter, a 7-day course of the second oral Tocagen drug will be taken at one of 2 doses.
- Follow-up for adverse events continues for 12 weeks.
LOCATIONS AND CONTACTS:
Your doctor may contact study contacts to determine locations and eligibility.
Contact: Asha Das, MD | 858-412-8468 | [email protected]
Contact: Mary Lovely | 858-412-8473 | [email protected]
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