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

NCT00393809 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-01-07

No results posted yet for this study

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.

Conditions

  • Bladder Neoplasms

Interventions

DRUG

DTA-H19

Sponsors & Collaborators

  • Anchiano Therapeutics Israel Ltd.

    collaborator INDUSTRY

  • Hebrew University of Jerusalem

    lead OTHER

Principal Investigators

  • Abraham Sidi, MD · E. Wolfson Medical Center

  • Ilan Leibovitch, MD · Meir Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00393809 on ClinicalTrials.gov