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Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

This study is currently recruiting participants.
Verified September 2010 by University of Pennsylvania
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01212367
First received: September 29, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 29, 2010
September 29, 2010
February 2009
December 2027   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Identify the maximum tolerated dose of SCH 721015 separated by a three day interval [ Time Frame: On going throughout the conduct of the trial ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intrapleural Gene Transfer for Pleural Mesothelioma
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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
  • 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 1
    Intervention: Biological: SCH 721015
  • Experimental: Dose Level 2
    This is a dose de escalation.
    Intervention: Biological: SCH 721015
Sterman DH, Haas A, Moon E, Recio A, Schwed D, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Papasavvas E, Montaner LJ, Heitjan DF, Litzky L, Friedberg J, Culligan M, June CH, Carroll RG, Albelda SM. A trial of intrapleural adenoviral-mediated Interferon-?2b gene transfer for malignant pleural mesothelioma. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1395-9. Epub 2011 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2027
December 2027   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Adri Recio, RN, BA 215-573-6760 arecio@mail.med.upenn.edu
Contact: Joan Gilmore, BS 215-746-8902 jgilmore@mail.med.upenn.edu
United States
 
NCT01212367
UPCC 18508, P01CA066726
Yes
Daniel H. Sterman, MD, Associate Professor of Medicine, University of Pennsylvania
University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Daniel H Sterman, M.D. University of Pennsylvania
University of Pennsylvania
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP