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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Cell Genesys

Study Description
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Brief Summary:
The main purpose of this research study is to evaluate the safety and dosing of CG0070.

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Bladder Neoplasms Biological: Oncolytic adenovirus (serotype 5) - CG0070 Phase 1

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder


Outcome Measures
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Primary Outcome Measures :
  1. Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [ Time Frame: Study End ]

Secondary Outcome Measures :
  1. Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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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
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:
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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
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs