Gene Therapy for Pleural Malignancies

Status Completed

Clinical Trial Summary

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:

- malignant pleural mesothelioma, or

- pleural effusions who have progressed through at least one prior therapy or have refused therapy

BG00001 is given twice through a catheter in the pleural space.

Clinical Trial Description

Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.

Five dose levels will be studied:

- Dose levels 1, 2, and 3 will be given on Days 1 and 15

- Dose levels 4 and 5 will be given on Days 1 and 8 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00299962
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 1
Start date	March 2006
Completion date	October 2009

View Details

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