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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by Cell Genesys.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Cell Genesys

ClinicalTrials.gov Identifier:

NCT00109655

First received: May 2, 2005

Last updated: October 1, 2008

Last verified: October 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	May 2, 2005
Last Updated Date	October 1, 2008
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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00109655 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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	Active, not recruiting
Estimated Enrollment ^ICMJE	75
Estimated Completion Date	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00109655
Other Study ID Numbers ^ICMJE	V-0046
Has Data Monitoring Committee	Not Provided
Responsible Party	Cell Genesys, Inc
Study Sponsor ^ICMJE	Cell Genesys
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cell Genesys
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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