Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania Identifier:
First received: September 29, 2010
Last updated: September 21, 2015
Last verified: September 2015

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.

Condition Intervention Phase
Malignant Pleural Mesothelioma
Biological: SCH 721015
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma

Resource links provided by NLM:

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Dose Level 2
This is a dose de escalation.
Biological: SCH 721015
3.0 x 10e11 viral particles on Days 1 and 4
Other Names:
  • Adenoviral-mediated Interferon-alpha
  • Ad.IFN-alpha

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01212367

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Daniel Sterman University of Pennsylvania
  More Information

No publications provided by Abramson Cancer Center of the University of Pennsylvania

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01212367     History of Changes
Other Study ID Numbers: UPCC 18508; 808806, P01CA066726
Study First Received: September 29, 2010
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Gene transfer

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Mesothelial
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 02, 2015