Clinical Trials for Mesothelioma Patients—Gene Therapy for Pleural Malignancies: Outcome Measures

Read the outcome measures for a current clinical trial on gene therapy being conducted on patients with advanced cancer or malignant mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. This trial is currently only being conducted in Switzerland.

Primary Outcome Measures:

• To determine the MTD/MED and toxicity of two doses of intrapleural BG00001 (Ad.hIFN-ß).

• To analyze Ad.hIFN-ß gene transfer with two doses (via pleural fluid ELISA for IFN-ß).

Secondary Outcome Measures:

• To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation.

• To assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.

Estimated Enrollment: 15

Study Start Date: March 2006

Estimated Study Completion Date: March 2008

Detailed Description:

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