• - To determine the MTD/MED and toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β).
• - To analyze Ad.hIFN-β gene transfer with two doses (via pleural fluid ELISA for IFN-β).

• - 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.

This Phase I study will evaluate the safety of two doses of BG00001. 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, on Day 1 and Day 15. BG00001 is given through a catheter in the pleural space.

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.

• Pleural Mesothelioma
• Metastatic Pleural Effusions

Inclusion Criteria:

• pathologically documented malignant pleural effusion from malignant mesothelioma or, metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
• must have evaluable disease
• must have ECOG performance status of 0 or 1
• must have pleural space involved with tumor accessible for pleural catheter
• must have FEV1 > 1 liter or 40% of predicted value
• must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001

Exclusion Criteria:

• malignant pleural effusions secondary to lymphoma
• rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
• presence of known untreated brain metastases
• use of concurrent systemic steroids or immunosuppressants