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

Sponsor

Cell Genesys (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00109655

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2005

Anticipated Primary Completion Date :

Oct 1, 2008

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Biological: Oncolytic adenovirus (serotype 5) - CG0070

Intravesical administration of CG0070 (in suspension) directly into the bladder

Outcome Measures

Primary Outcome Measures

Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration [Study End]

Secondary Outcome Measures

Assessment of the amount of CG0070 in the urine and blood over time by PCR [Study End]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	BCG Oncology	Phoenix	Arizona	United States	85032
2	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94143
3	Billings Clinic	Billings	Montana	United States	59107
4	New York Oncology Hematology	Albany	New York	United States	12208
5	Columbia University	New York	New York	United States	10032
6	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605
7	Mary Crowley Medical Research Center	Dallas	Texas	United States	75246
8	Baylor College of Medicine	Houston	Texas	United States	77030
9	Male/Female Health and Research Centre	Barrie	Ontario	Canada	L4M 7G1
10	The Fe/Male Health Centre	Oakville	Ontario	Canada	L6H 3P1