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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

Tracking Information
First Submitted Date  ICMJE May 2, 2005
First Posted Date  ICMJE May 3, 2005
Last Update Posted Date October 3, 2008
Study Start Date  ICMJE April 2005
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)		 Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [ Time Frame: Study End ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)		 Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Official Title  ICMJE A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
Brief Summary The main purpose of this research study is to evaluate the safety and dosing of CG0070.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Transitional Cell
  • Bladder Neoplasms
Intervention  ICMJE Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
Study Arms  ICMJE Experimental: 1
Intervention: Biological: Oncolytic adenovirus (serotype 5) - CG0070
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2006)		 75
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		 36
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00109655
Other Study ID Numbers  ICMJE V-0046
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cell Genesys, Inc
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Cell Genesys
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cell Genesys
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP