Status:
COMPLETED
Gene Therapy for Pleural Malignancies
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Cancer Institute (NCI)
Biogen
Conditions:
Pleural Mesothelioma
Metastatic Pleural Effusions
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pr...
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 toler...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00299962
Start Date
March 1 2006
End Date
October 1 2009
Last Update
March 18 2020
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104