Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

September 21, 2015 updated by: Abramson Cancer Center of the University of Pennsylvania

A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
Biological: SCH 721015
1.0 x 10e12 viral particles on Days 1 and 4
Other Names:
  • Adenoviral-mediated Interferon-alpha
  • Ad.IFN-alpha
Biological: SCH 721015
3.0 x 10e11 viral particles on Days 1 and 4
Other Names:
  • Adenoviral-mediated Interferon-alpha
  • Ad.IFN-alpha
Experimental: Dose Level 2
This is a dose de escalation.
Biological: SCH 721015
1.0 x 10e12 viral particles on Days 1 and 4
Other Names:
  • Adenoviral-mediated Interferon-alpha
  • Ad.IFN-alpha
Biological: SCH 721015
3.0 x 10e11 viral particles on Days 1 and 4
Other Names:
  • Adenoviral-mediated Interferon-alpha
  • Ad.IFN-alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After the first dose and at each visit until day 94

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Daniel Sterman, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 18508; 808806
  • P01CA066726 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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