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
1 other identifier
interventional
75
2 countries
10
Brief Summary
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2005
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 2, 2005
CompletedFirst Posted
Study publicly available on registry
May 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 3, 2008
October 1, 2008
3.5 years
May 2, 2005
October 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
Study End
Secondary Outcomes (1)
Assessment of the amount of CG0070 in the urine and blood over time by PCR
Study End
Study Arms (1)
1
EXPERIMENTALInterventions
Intravesical administration of CG0070 (in suspension) directly into the bladder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell Genesyslead
Study Sites (10)
BCG Oncology
Phoenix, Arizona, 85032, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143, United States
Billings Clinic
Billings, Montana, 59107, United States
New York Oncology Hematology
Albany, New York, 12208, United States
Columbia University
New York, New York, 10032, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1, Canada
The Fe/Male Health Centre
Oakville, Ontario, L6H 3P1, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2005
First Posted
May 3, 2005
Study Start
April 1, 2005
Primary Completion
October 1, 2008
Study Completion
September 1, 2010
Last Updated
October 3, 2008
Record last verified: 2008-10