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Sponsors and Collaborators: |
University of Pennsylvania Biogen Idec |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00299962 |
This Phase I study will evaluate the safety of two doses of BG00001. Eligible subjects will have:
BG00001 is given twice, on Day 1 and Day 15. BG00001 is given through a catheter in the pleural space.
Condition | Intervention | Phase |
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Pleural Mesothelioma Metastatic Pleural Effusions |
Gene Transfer: BG00001 (adenoviral-mediated interferon-beta) |
Phase I |
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 |
Estimated Enrollment: | 15 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adri Recio, RN | 215-573-6760 | arecio@mail.med.upenn.edu |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Daniel H. Sterman, M.D. | University of Pennsylvania |
Study ID Numbers: | 803776, UPCC 03505 |
Study First Received: | March 3, 2006 |
Last Updated: | March 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00299962 |
Health Authority: | United States: Food and Drug Administration |
gene therapy immunotherapy |
Pleural Effusion Respiratory Tract Diseases Pleural Diseases Interferons |
Interferon-beta Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Neoplasms, Mesothelial Therapeutic Uses Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions |