Gene Therapy for Pleural Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pennsylvania
Collaborators:
Biogen Idec
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00299962
First received: March 3, 2006
Last updated: September 29, 2010
Last verified: September 2010
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Purpose
This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:
- malignant pleural mesothelioma, or
- pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space.
| Condition | Intervention | Phase |
|---|---|---|
|
Pleural Mesothelioma Metastatic Pleural Effusions |
Biological: Adenoviral-mediated Interferon-beta 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 Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and [ Time Frame: Through Day 85 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation, [ Time Frame: Through Day 85 ] [ Designated as safety issue: No ]
- and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival. [ Time Frame: 15 years or until subject dies, whichever comes first ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | April 2023 |
| Estimated Primary Completion Date: | April 2023 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose level 4 |
Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Other Name: adenoviral-mediated Interferon-beta
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
|
| Experimental: Dose level 5 |
Biological: Adenoviral-mediated Interferon-beta
BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
Other Name: adenoviral-mediated Interferon-beta
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
|
|
Experimental: Dose Level 1
on Days 1 and 15
|
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
|
|
Experimental: Dose Level 2
On Days 1 and 15
|
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
|
|
Experimental: Dose Level 3
On Days 1 and 15
|
Biological: SCH 721015
Comparison of different doses and frequency of investigational agent
Other Names:
|
Detailed Description:
Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.
Five dose levels will be studied:
- Dose levels 1, 2, and 3 will be given on Days 1 and 15
- Dose levels 4 and 5 will be given on Days 1 and 8
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
- must have evaluable disease
- must have ECOG performance status of 2
- must have pleural space involved with tumor accessible for pleural catheter
- must have FEV1 > 1 liter or 40% of predicted value
- must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001
- concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events
- patients on stable dose of hormone may continue use of hormone
- patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva
Exclusion Criteria:
- malignant pleural effusions secondary to lymphoma
- rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
- untreated brain metastases
- use of concurrent systemic steroids or immunosuppressants
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299962
Locations
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
University of Pennsylvania
Biogen Idec
Investigators
| Principal Investigator: | Daniel H. Sterman, M.D. | University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | Daniel H. Sterman, M.D., University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00299962 History of Changes |
| Other Study ID Numbers: | 803776, P01CA066726 |
| Study First Received: | March 3, 2006 |
| Last Updated: | September 29, 2010 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
gene therapy immunotherapy |
Additional relevant MeSH terms:
|
Mesothelioma Pleural Effusion Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Pleural Diseases Respiratory Tract Diseases |
Interferon-beta Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013