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

NCT00393809 | Completed Phase 1

• 1 other identifier: BC-05-02.CTIL
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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 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

Keywords

transitional cell carcinoma; H19 gene; plasmid; diphtheria toxin

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose (MTD)

Secondary Outcomes (3)

• The percentage increase or reduction in the area of marker lesions

• The number of patients with progressive disease

• The time to disease progression

Interventions

DTA-H19 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead
• Anchiano Therapeutics Israel Ltd.: collaborator

Study Sites (2)

E. Wolfson Medical Center

Holon, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Abraham Sidi, MD

  E. Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Ilan Leibovitch, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 30, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 7, 2008

Record last verified: 2007-12

Locations

IL (2)