Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)
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|ClinicalTrials.gov Identifier: NCT01212367|
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : September 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Biological: SCH 721015||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212367
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Daniel Sterman||University of Pennsylvania|