Status:
COMPLETED
Safety and Proof of Concept Study of Intravesical DTA-H19 in Patients With Superficial Bladder Cancer
Lead Sponsor:
Hebrew University of Jerusalem
Collaborating Sponsors:
Anchiano Therapeutics Israel Ltd.
Conditions:
Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00393809
Start Date
January 1 2006
End Date
December 1 2007
Last Update
January 7 2008
Active Locations (2)
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1
E. Wolfson Medical Center
Holon, Israel
2
Meir Medical Center
Kfar Saba, Israel