Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by University of Pennsylvania
Sponsor:
Collaborator:
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
  Purpose

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 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: February 2009
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: December 2027 (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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01212367

Contacts
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

Locations
United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Adri Recio, RN, BA    215-573-6760    arecio@mail.med.upenn.edu   
Principal Investigator: Daniel H. Sterman, M.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Daniel H Sterman, M.D. University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel H. Sterman, MD, Associate Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01212367     History of Changes
Other Study ID Numbers: UPCC 18508, P01CA066726
Study First Received: September 29, 2010
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Gene transfer
Immunology
Cancer

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014