Intrapleural Gene Transfer for Pleural Mesothelioma
Completed · Phase 1
Conditions studied: Malignant Pleural Mesothelioma
In brief
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.
Key facts
- Study ID
- NCT01212367
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 13
- Starts
- 2009-02-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2015-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.