Spots Global Cancer Trial Database for Gene Therapy for Pleural Malignancies

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Gene Therapy for Pleural Malignancies

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

Study ID: NCT00299962

Conditions

Pleural Mesothelioma

Metastatic Pleural Effusions

Interventions

Adenoviral-mediated Interferon-beta

SCH 721015

Study Description

Brief 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