Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
NCT ID: NCT00109655
Last Updated: 2008-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
75 participants
INTERVENTIONAL
2005-04-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
Interventions
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Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cell Genesys
INDUSTRY
Responsible Party
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Cell Genesys, Inc
Locations
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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
Countries
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Related Links
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Related Info
Other Identifiers
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V-0046
Identifier Type: -
Identifier Source: org_study_id