A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma
Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective
recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This
Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two
doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart
in subjects with pleural mesothelioma.
Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first
dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and
overnight observation. Subjects are then followed-up as outpatients for a total of 6
months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural
catheter is removed once it is not necessary.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To analyze gene transfer with two does separated by three-day interval
After the first dose and at each visit until day 94
Daniel H Sterman, M.D.
University of Pennsylvania
United States: Food and Drug Administration
|University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|