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Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

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ClinicalTrials.gov Identifier: NCT01212367
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : September 22, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Biological: SCH 721015 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

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

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212367

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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)
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Principal Investigator: Daniel Sterman University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01212367    
Other Study ID Numbers: UPCC 18508; 808806
P01CA066726 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Gene transfer
Additional relevant MeSH terms:
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Mesothelioma, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs