Gene Therapy for Pleural Malignancies
This trial is active, not recruiting.
|Conditions||pleural mesothelioma, metastatic pleural effusions|
|Treatments||adenoviral-mediated interferon-beta, sch 721015|
|Sponsor||University of Pennsylvania|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2006|
|End date||April 2023|
|Trial size||18 participants|
|Trial identifier||NCT00299962, 803776, P01CA066726|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
time frame: Through Day 85
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
time frame: Through Day 85
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
Male or female participants at least 18 years old.
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
|Official title||A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies|
|Principal investigator||Daniel H. Sterman, M.D.|
|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|
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