Lung Cancer Trials Ask AI to find trials
CompletedPhase 1NCT01212367
Official study title

Intrapleural Gene Transfer for Pleural Mesothelioma

Study 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 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSCH 721015 and SCH 721015

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 22, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Abramson Cancer Center at Penn Medicine

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Treatment approach
Cell or gene therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

View original record ↗