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

Status unconfirmed · Phase 1

Conditions studied: Carcinoma, Transitional Cell, Bladder Neoplasms

In brief

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

Key facts

Study ID

NCT00109655

Run by

Cell Genesys

People needed

75

Starts

2005-04-01

Expected to finish

2010-09-01

Last updated by the study team

2008-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• BCG Oncology — Phoenix, Arizona, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• Billings Clinic — Billings, Montana, United States
• New York Oncology Hematology — Albany, New York, United States
• Columbia University — New York, New York, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Male/Female Health and Research Centre — Barrie, Ontario, Canada
• The Fe/Male Health Centre — Oakville, Ontario, Canada

Full record on ClinicalTrials.gov

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