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Sponsored by: |
Cell Genesys |
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Information provided by: | Cell Genesys |
ClinicalTrials.gov Identifier: | NCT00109655 |
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Condition | Intervention | Phase |
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Carcinoma, Transitional Cell Bladder Neoplasms |
Biological: Oncolytic adenovirus (serotype 5) - CG0070 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure |
Estimated Enrollment: | 75 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
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Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
BCG Oncology | |
Phoenix, Arizona, United States, 85032 | |
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Montana | |
Billings Clinic | |
Billings, Montana, United States, 59107 | |
United States, New York | |
New York Oncology Hematology | |
Albany, New York, United States, 12208 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, South Carolina | |
Cancer Centers of the Carolinas | |
Greenville, South Carolina, United States, 29605 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75246 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Canada, Ontario | |
Male/Female Health and Research Centre | |
Barrie, Ontario, Canada, L4M 7G1 | |
The Fe/Male Health Centre | |
Oakville, Ontario, Canada, L6H 3P1 |
Responsible Party: | Cell Genesys, Inc ( Cell Genesys, Inc ) |
Study ID Numbers: | V-0046 |
Study First Received: | May 2, 2005 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00109655 |
Health Authority: | United States: Food and Drug Administration |
Superficial Transitional Cell Carcinoma Bacillus Calmette-Guerin (BCG) Superficial Bladder Cancer Gene Therapy |
Vaccine Adenovirus Carcinoma in situ |
BCG Vaccine Cystocele Adenoviridae Infections Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms |
Transitional cell carcinoma Carcinoma Urologic Diseases Carcinoma in Situ Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |