Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Cell Genesys.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cell Genesys
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00109655
First received: May 2, 2005
Last updated: October 1, 2008
Last verified: October 2008
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Purpose
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Transitional Cell Bladder Neoplasms |
Biological: Oncolytic adenovirus (serotype 5) - CG0070 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
BCG Vaccine
U.S. FDA Resources
Further study details as provided by Cell Genesys:
Primary Outcome Measures:
- Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [ Time Frame: Study End ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Experimental: 1 |
Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
- Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
- ECOG performance status 0-1
- Adequate bone marrow, renal, liver and coagulation function
Exclusion Criteria:
- Pregnant or nursing
- HIV positive
- Use of anticoagulants such as coumadin or heparin
- History of bleeding disorder
- Active systemic autoimmune disease or chronic immunodeficiency
- Prior gene therapy
- Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109655
Locations
| 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 | |
Sponsors and Collaborators
Cell Genesys
More Information
Additional Information:
No publications provided
| Responsible Party: | Cell Genesys, Inc |
| ClinicalTrials.gov Identifier: | NCT00109655 History of Changes |
| Other Study ID Numbers: | V-0046 |
| Study First Received: | May 2, 2005 |
| Last Updated: | October 1, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cell Genesys:
|
Superficial Transitional Cell Carcinoma Bacillus Calmette-Guerin (BCG) Superficial Bladder Cancer Gene Therapy |
Vaccine Adenovirus Carcinoma in situ |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Neoplasms Carcinoma Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases |
Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type BCG Vaccine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013