NCT00109655

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Cell Genesys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Transitional Cell
• Bladder Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic adenovirus (serotype 5) - CG0070	Intravesical administration of CG0070 (in suspension) directly into the bladder

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-10-01
• Completion: 2010-09-01
• First posted: 2005-05-03
• Last updated: 2008-10-03

Locations

10 sites across 2 countries: United States, Canada