Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)
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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 |
- 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 ]
- 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:
|
|
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:
|
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 |
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| 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, 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. | |
| 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 Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Interferon-alpha Interferon Alfa-2a Interferons Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013