NCT00299962

Gene Therapy for Pleural Malignancies

A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pleural Mesothelioma
• Metastatic Pleural Effusions

Interventions

Type	Name	Description
BIOLOGICAL	Adenoviral-mediated Interferon-beta	BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
BIOLOGICAL	SCH 721015	Comparison of different doses and frequency of investigational agent

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-05-01
• Completion: 2009-10-01
• First posted: 2006-03-07
• Last updated: 2020-03-18

Locations

1 site across 1 country: United States