Safety and Proof of Concept Study of Intravesical DTA-H19 in Patients With Superficial Bladder Cancer

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the safety and preliminary efficacy of five different doses of DTA-H19 given as six intravesical infusions into the bladder of patients with superficial bladder cancer who have failed intravesical therapy with Bacille Calmette-Guérin (BCG).DTA-H19 is a DNA plasmid that contains H19 gene regulatory sequences that drive the expression of an intracellular toxin [diphtheria toxin A (DTA) chain]only in cancer cells and not in normal cells. In line with the standard procedure for DNA plasmid pharmaceutical products, another chemical component will be added to the solution, called PEI (polyethlenimine) in a liquid solution, which improves the ability of the DNA plasmid to enter the cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebrew University of Jerusalem
• Collaborators: Anchiano Therapeutics Israel Ltd.; BioCancell Ltd.

Criteria

Inclusion Criteria:

• Patients must have superficial transitional cell carcinoma of the bladder (stages Ta and/or CIS)

• Tumor biopsies must be shown to be positive for H19 gene by in situ hybridization

• Patients must have failed intravesical treatment with BCG

Exclusion Criteria:

• Patients with grade 3, or Stage 1 or higher stage TCC of the bladder

• Patients with any other malignancy that might impact 5-year survival or might be potentially confused with TCC