Mesothelioma Related Clinical Trials:
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Beta (BG00001, Ad.hIFN-β for Pleural Malignancies
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Status: Recruiting
Sponsors and Collaborators: University of Pennsylvania; Biogen Idec
Information provided by: University of Pennsylvania
Government Identifier: NCT00299962
Condition: Pleural Mesothelioma; Metastatic Pleural Effusions
Intervention: Gene Transfer: BG00001 (adenoviral-mediated interferon-beta)
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Purpose:
This Phase I study will evaluate the safety of two doses of BG00001. 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, on Day 1 and Day 15. BG00001 is given through a catheter in the pleural space.
| Study Type: |
Interventional |
| Study Design: |
Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
|
| Official Title: |
A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Beta (BG00001, Ad.hIFN-β for Pleural Malignancies |
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- - To determine the MTD/MED and toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β).
- - To analyze Ad.hIFN-β gene transfer with two doses (via pleural fluid ELISA for IFN-β).
Secondary Outcome Measures:
- - To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation.
- - To assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
| Estimated Enrollment: |
15 |
| Study Start Date: |
March 2006 |
| Estimated Study Completion Date: |
March 2008 |
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.
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Eligibility:
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Criteria
Inclusion Criteria:
- pathologically documented malignant pleural effusion from malignant mesothelioma or, metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
- must have evaluable disease
- must have ECOG performance status of 0 or 1
- 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
Exclusion Criteria:
- malignant pleural effusions secondary to lymphoma
- rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
- presence of known untreated brain metastases
- use of concurrent systemic steroids or immunosuppressants
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Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299962
Contacts
|
| Contact: Adri Recio, RN |
215-573-6760 |
arecio@mail.med.upenn.edu |
Locations
|
| United States, Pennsylvania |
|
Hospital of the University of Pennsylvania |
|
Recruiting |
|
Philadelphia, Pennsylvania, United States, 19104 |
Sponsors and Collaborators
|
| University of Pennsylvania |
|
| Biogen Idec |
Investigators
|
| Principal Investigator: |
Daniel H. Sterman, M.D. |
University of Pennsylvania |
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Additional Information:
| Study ID Numbers: |
803776, UPCC 03505 |
| First Received: |
March 3, 2006 |
| Last Updated: |
March 3, 2006 |
| ClinicalTrials.gov Identifier: |
NCT00299962 |
| Health Authority: |
United States: Food and Drug Administration |
Keywords provided by University of Pennsylvania:
| gene therapy |
| immunotherapy |
|
Study placed in the following topic categories:
| Pleural Effusion |
| Pleural Diseases |
| Interferons |
| Benfluorex |
| Interferon-beta |
|
|
| Mesothelioma |
| Interferon Alfa-2b |
| Adenoma |
| Neoplasms, Glandular and Epithelial |
|
Additional relevant MeSH terms:
| Mesothelioma |
| Anti-Infective Agents |
| Neoplasms |
| Neoplasms by Histologic Type |
| Immunologic Factors |
| Respiratory Tract Diseases |
|
|
| Antineoplastic Agents |
| Neoplasms, Mesothelial |
| Therapeutic Uses |
| Physiological Effects of Drugs |
| Antiviral Agents |
| Pharmacologic Actions |
|
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