Bladder Neoplasms, Carcinoma, Transitional Cell
Conditions
Keywords
Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ
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.
Interventions
BIOLOGICALOncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder
Sponsors
Cell Genesys
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration | Study End |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the amount of CG0070 in the urine and blood over time by PCR | Study End |
Countries
Canada, United States
Outcome results
None listed