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
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Cell Genesys, Inc
ClinicalTrials.gov Identifier: NCT00109655     History of Changes
Other Study ID Numbers: V-0046
Study First Received: May 2, 2005
Last Updated: October 1, 2008
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

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Carcinoma
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014