Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)
This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma|
- To analyze gene transfer with two does separated by three-day interval [ Time Frame: After the first dose and at each visit until day 94 ] [ Designated as safety issue: No ]
- Identify the maximum tolerated dose of SCH 721015 separated by a three day interval [ Time Frame: On going throughout the conduct of the trial ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2027|
|Estimated Primary Completion Date:||December 2027 (Final data collection date for primary outcome measure)|
|Experimental: Dose Level 1||
Biological: SCH 721015
1.0 x 10e12 viral particles on Days 1 and 4
Experimental: Dose Level 2
This is a dose de escalation.
Biological: SCH 721015
3.0 x 10e11 viral particles on Days 1 and 4
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.
|Contact: Adri Recio, RN, BAemail@example.com|
|Contact: Joan Gilmore, BSfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Adri Recio, RN, BA 215-573-6760 email@example.com|
|Principal Investigator: Daniel H. Sterman, M.D.|
|Principal Investigator:||Daniel H Sterman, M.D.||University of Pennsylvania|