Clinical Trials A Phase 1/2 Ascending Dose Trial with Extended Cohort of the Safety and Tolerability of Toca 511 with 5-FC in Patients with Recurrent Gliobalstoma Multiforme The first human study of Toca 511 with 5-FC will be conducted in subjects who have recurrent Glioblastoma Multiforma (GBM). These are subjects whose tumor has recurred despite surgery, radiation therapy and treatment with temozolomide. Subjects must be between 18 and 75 years of age and have a single tumor recurrence that measures between 1.5 and 3 cm inclusive, in its longest dimension. The study will be conducted at three of the top neuro-oncology centers in the United States. The study will be conducted in two parts. Part one will study increasing single doses of Toca 511 delivered by stereotactic injection through a small burr hole into the tumor. Approximately 3 weeks later subjects will begin a 6-day course of oral flucytosine (5-FC). If tolerated, these 6-day courses of 5-FC will be repeated monthly for 6 months. The major focus of part one of the study is to identify the highest safe and tolerated dose of Toca 511.  Gadolinium-enhanced MRI scan will performed every two months for 6 months to asses tumor size. Approximately 15 subjects will be enrolled in part one of the study. In part two of the study, the highest safe and tolerated dose of Toca 511 identified in part one of the study, will be administered to nine more subjects. As in part one, Toca 511 will be delivered once through a small burr hole into the tumor. Approximately 3 weeks later subjects will begin a 6-day course of oral 5-FC, and if tolerated, these 6-day courses of 5-FC will be repeated monthly for 6 months. Part two of the study will focus on safety as well as tumor response as assessed by gadolinium-enhanced MRI scan performed every two months for 6 months.   If you are a physician who would like more information regarding the eligibility of one of your patients, please contact us through the Physician Inquiry Form. If you are a patient and would like more information regarding your eligibility for this study, please contact us through the Patient Inquiry Form.     Programs  Brain Cancer (GBM)  Malignant Melanoma   Product Candidates  Prodrug Activator: Toca 511  Immunotherapeutic: Toca 621    Also see: Breakthrough Technology

Participating Study Centers     UCLA   Principal Investigator, Tim Cloughesy, MD   Contact Emese Filka, Clinical Trials Coordinator,      at 310-794-3521.     UCSF   Principal Investigator, Manish Aghi, MD   Cleveland Clinic Foundation   Principal Investigator, Michael Vogelbaum, MD                              Clinical Trial Listings       ClinicalTrals.gov Clinical Trial Listing         CenterWatch Clinical Trial Listing          VirtualTrials Trial Listing         National Cancer Institute Trial Listing                                                                   Related Brain Cancer Resources     Accelerate Brain Cancer Cure   American Brain Tumor Association   American Cancer Society     Dictionary of Cancer Terms   National Brain Tumor Society   National Cancer Institute   National Institutes of Health   Voices Against Brain Cancer

Privacy Policy | Terms of Use | www.tocagen.com   3030 Bunker Hill St. Suite 230  San Diego, CA 92109          Main (858) 412-8400  Fax (858) 412-8499  © Copyright 2010 Tocagen Inc.