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

Purpose

The main purpose of this research study is to evaluate the safety and dosing of CG0070.

Condition	Intervention	Phase
Carcinoma, Transitional Cell Bladder Neoplasms	Biological: Oncolytic adenovirus (serotype 5) - CG0070	Phase I

Genetics Home Reference related topics:

bladder cancer

MedlinePlus related topics:

Bladder Cancer Cancer

ChemIDplus related topics:

BCG Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Official Title:	A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure

Further study details as provided by Cell Genesys:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Assessment of the amount of CG0070 in the urine and blood over time by PCR [ Time Frame: Study End ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	April 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Oncolytic adenovirus (serotype 5) - CG0070 Intravesical administration of CG0070 (in suspension) directly into the bladder

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109655

Locations


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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Cell Genesys, Inc ( Cell Genesys, Inc )
Study ID Numbers:	V-0046
First Received:	May 2, 2005
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00109655
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Superficial Transitional Cell Carcinoma

Bacillus Calmette-Guerin (BCG)

Superficial Bladder Cancer

Gene Therapy

Vaccine

Adenovirus

Carcinoma in situ

Study placed in the following topic categories:

BCG Vaccine

Adenoviridae Infections

Urinary Bladder Diseases

Urinary Bladder Neoplasms

Urogenital Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Transitional cell carcinoma

Carcinoma

Urologic Diseases

Carcinoma in Situ

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Immunologic Factors

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00109655