Bladder Cancer Clinical Trial

Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

Summary

The main purpose of this research study is to evaluate the safety and dosing of CG0070.

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Full 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.

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Eligibility 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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT00109655

Recruitment Status:

Unknown status

Sponsor:

Cell Genesys

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There are 10 Locations for this study

See Locations Near You

BCG Oncology
Phoenix Arizona, 85032, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94143, United States
Billings Clinic
Billings Montana, 59107, United States
New York Oncology Hematology
Albany New York, 12208, United States
Columbia University
New York New York, 10032, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States
Mary Crowley Medical Research Center
Dallas Texas, 75246, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Male/Female Health and Research Centre
Barrie Ontario, L4M 7, Canada
The Fe/Male Health Centre
Oakville Ontario, L6H 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT00109655

Recruitment Status:

Unknown status

Sponsor:


Cell Genesys

How clear is this clinincal trial information?

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