Status:
COMPLETED
Intrapleural Gene Transfer for Pleural Mesothelioma
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
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 des...
Eligibility Criteria
Inclusion
- evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
- evaluable disease
- No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
- Must have a pleural space involved with tumor accessible for pleural catheter insertion
- FEV1\> 1 liter or 40% of predicted value
- Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core
Exclusion
- Presence of HIV or Hepatitis B infection
- Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
- Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
- Presence of untreated brain metastases
- Prior bone marrow or stem cell transplants
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01212367
Start Date
February 1 2009
End Date
May 1 2015
Last Update
September 22 2015
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104