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

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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
Information provided by:
Cell Genesys

May 2, 2005
May 3, 2005
October 3, 2008
April 2005
October 2008   (Final data collection date for primary outcome measure)
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [ Time Frame: Study End ]
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Complete list of historical versions of study NCT00109655 on ClinicalTrials.gov Archive Site
Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ]
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Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Transitional Cell
  • Bladder Neoplasms
Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
Experimental: 1
Intervention: Biological: Oncolytic adenovirus (serotype 5) - CG0070
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2010
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Cell Genesys, Inc
Cell Genesys
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Cell Genesys
October 2008

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