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Clinical Trials
Standard treatment for newly diagnosed high grade glioma (Grade 3 or Grade 4) includes surgical removal of as much of the tumor as possible followed by radiation therapy and chemotherapy with temozolomide. Unfortunately, despite these measures, the tumor often recurs. Tocagen is performing multicenter Phase 1 studies of its novel retroviral replicating vector, Toca 511, used in conjunction with Toca FC (5-FC), for treatment of those tumors that have recurred following surgery, radiation and chemotherapy. Subjects must be at least 18 years of age and have a single tumor upon recurrence. The studies are being conducted at leading neuro-oncology centers in the United States.
Study 1 (Intratumoral injection of Toca 511)
This study focuses on patients with recurrent high grade glioma whose tumor recurrence is still relatively small (≤ 9 cm2 in its greatest cross sectional area). Because these tumors may grow rapidly, patients are encouraged to discuss this study with their doctor as soon as a recurrence becomes apparent.
The study is conducted in two parts. Part one is studying increasing single intratumoral doses of Toca 511 delivered by stereotactic injection into the tumor through a small hole in the skull. Approximately 4 weeks after injection of Toca 511 subjects begin a 6-day course of oral Toca FC. If tolerated, these 6-day courses of Toca-FC will be repeated monthly for up to 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 scans will be performed every two months for 6 months to assess tumor size. Approximately 21 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 into the tumor through a small hole in the skull. Approximately 4 weeks after injection subjects will begin a 6-day course of oral Toca FC, and if tolerated, these 6-day courses of Toca FC will be repeated monthly for up to 6 months. Part two of the study will focus on safety as well as tumor response as assessed by gadolinium-enhanced MRI scans performed every 2 months for 6 months.
For more information, please visit: http://clinicaltrials.gov/ct2/show/NCT01156584?term=tocagen&rank=2
Study 2 (Injection of Toca 511 at the time of tumor removal)
This study focuses on patients with recurrent high grade glioma who have decided to have surgery to remove their tumor. In order to participate in this study, the tumor recurrence must measure less than 6 cm in its greatest dimension and the surgeon estimates that at least 80% of the tumor can be removed at surgery. Immediately following removal (“resection”) of the tumor, Toca 511 will be injected into the bed of the resection cavity. Approximately 7 weeks after injection subjects will begin an 8-day course of oral Toca FC. If tolerated, these 8-day courses of Toca-FC will be repeated every 8 weeks for a total of 3 courses during the 6-month study. The major focus of the study is to identify the highest safe and tolerated dose of Toca 511. Gadolinium-enhanced MRI scan will be performed every two months for 6 months to assess the effect of treatment. Approximately 15 subjects will be enrolled in this study.
For more information, please visit: http://clinicaltrials.gov/ct2/show/NCT01470794?term=tocagen&rank=1
Frequently Asked Questions:
Q: What is Toca 511?
A: Toca 511 is an investigational biologic drug composed of a retroviral replicating vector (virus) containing a cytosine deaminase (CD) gene.
Q: What is Toca FC?
A: Toca FC is an investigational extended-release oral drug containing 5-FC (flucytosine). It is intended to be used in combination with, and after administration of, Toca 511.
Q: What is Toca 511 & Toca FC?
A: Toca 511 & Toca FC is an investigational combination treatment that is designed to deliver high amounts of a cancer killing drug to the cancer tissue while leaving healthy tissue unharmed. In preclinical brain cancer studies in animals, Toca 511 & 5-FC (the active ingredient in Toca FC) was able to destroy tumors and prolong life in most animals treated.
Q: How areToca 511 & Toca FC administered?
A: Toca 511 is given by injection. Toca FC is taken orally.
Q: Is hospitalization required?
A: Yes. Toca 511 is administered in the hospital. All subsequent tests will be performed on an out-patient basis and Toca FC can be taken at home.
Q: What side effects can be expected?
A: Since the combination of Toca 511 & Toca FC is an investigational therapy, a complete safety profile has not been established. However, Toca 511 & Toca FC has not shown significant toxicity in animal safety studies and has been well tolerated by the human subjects dosed in the clinical study to date. Dose escalation in these studies is ongoing.
Q: What results are expected from the Toca 511 & Toca FC trial?
A: These studies are designed to assess the safety and tolerability of Toca 511 & Toca FC. Additionally, response to treatment will be assessed by measuring tumor size by brain scan (MRI) and progression free survival at 6 months (PFS-6).
Q: If I participate in this study, can I then participate in a vaccine trial?
A: Generally yes, but you should discuss your individual case with your doctor.
Q: How many sites will participate and where are the sites located?
A: Trial sites are located across the US. For an updated site list for the study you are interested in, please visit: http://clinicaltrials.gov and search for Toca 511.
Q: How can someone with a recurrent HGG participate in the clinical trial?
If you are a patient and would like more information regarding your eligibility for this study, please contact the study site location nearest you or contact Tocagen through the Patient Inquiry Form. For more information about this study and a complete listing of inclusion/exclusion criteria, please visit http://clinicaltrials.gov and search for Toca 511.
Q: How can a physician refer a patient with a recurrent HGG?
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.
Programs
Brain Cancer (High Grade Glioma)
Product Candidates
Toca 511 & Toca FC
Also see:
Breakthrough Technology
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Participating Study Centers
UCLA
Los Angeles, CA
Principal Investigator, Tim Cloughesy, MD
Contact Emese Filka, Study Coordinator,
at 310-794-3521.
UCSF
San Francisco, CA
Principal Investigator, Manish Aghi, MD
Contact Kristen Lawton, Study Coordinator,
at 415-353-2746
Cleveland Clinic Foundation
Cleveland, OH
Principal Investigator, Michael Vogelbaum, MD
Contact Cathy Brewer, RN, Study Coordinator,
at 216-444-7937
UCSD
San Diego, CA
Principal Investigator, Santosh Kesari, MD
Contact Ryan Kim, Study Coordinator
at rykim@ucsd.edu 858-822-6176
Henry Ford Hospital
Detroit, MI
Principal Investigator, Tom Mikkelsen, MD
Contact Amy Williamson, Study Coordinator
at awillia12@hfhs.org 313-916-3731
Clinical Trial Listings
ClinicalTrals.gov 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
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