Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
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ClinicalTrials.gov Identifier: NCT00109655 |
Recruitment Status : Unknown
Verified October 2008 by Cell Genesys.
Recruitment status was: Active, not recruiting
First Posted : May 3, 2005
Last Update Posted : October 3, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Transitional Cell Bladder Neoplasms | Biological: Oncolytic adenovirus (serotype 5) - CG0070 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2005 |
Estimated Primary Completion Date : | October 2008 |
Estimated Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder |
- Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [ Time Frame: Study End ]
- Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109655
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 |
ClinicalTrials.gov Identifier: | NCT00109655 |
Other Study ID Numbers: |
V-0046 |
First Posted: | May 3, 2005 Key Record Dates |
Last Update Posted: | October 3, 2008 |
Last Verified: | October 2008 |
Superficial Transitional Cell Carcinoma Bacillus Calmette-Guerin (BCG) Superficial Bladder Cancer Gene Therapy |
Vaccine Adenovirus Carcinoma in situ |
Carcinoma Carcinoma, Transitional Cell Urinary Bladder Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |