Overview

This trial is active, not recruiting.

Conditions carcinoma, transitional cell, bladder neoplasms
Treatment oncolytic adenovirus (serotype 5) - cg0070
Phase phase 1
Sponsor Cell Genesys
Start date April 2005
End date October 2008
Trial size 75 participants
Trial identifier NCT00109655, V-0046

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
oncolytic adenovirus (serotype 5) - cg0070
Intravesical administration of CG0070 (in suspension) directly into the bladder

Primary Outcomes

Measure
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
time frame: Study End

Secondary Outcomes

Measure
Assessment of the amount of CG0070 in the urine and blood over time by PCR
time frame: Study End

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Cell Genesys.