Intrapleural Gene Transfer for Pleural Mesothelioma
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.
Checked against the public recordLast updated Sep 22, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Interventions being studied
- Biological: SCH 721015; Biological: SCH 721015
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2015. Always confirm current availability with the study team.