Pleural Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Trial of Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma (MPM))
This study is being conducted to evaluate the overall safety and effectiveness of an investigational drug, GC1008, in patients with mesothelioma. An investigational drug is one that has not been approved by the FDA. Approximately 40 people will be enrolled on this study at the University of Pennsylvania (Main Institution/Coordinating Site) and the University of Chicago (Participating Institution). We expect about 20 subjects to be enrolled at each institution.
Primary: - To assess progression-free survival rate at three months.
Secondary: - To determine the toxicity and safety of systemic infusion of anti-TGF beta
antibody at three-week dosing intervals. - To assess time to progression and overall survival
- to assess response rate using Modified RECIST Criteria for Mesothelioma Additional
Objectives: - To assess efficacy using serial measurements of serum [and intrapleural, if
indwelling catheter in place] biomarkers, including serum-mesothelin related peptide
(SMRP/Mesomark®) and osteopontin. - To assess systemic [and intrapleural if indwelling
catheter in place] humoral anti-tumor immune responses after repeated anti-TGF beta antibody
instillation. - To assess systemic [and intrapleural, if indwelling catheter in place] TGF
beta, and other cytokine levels after repeated anti-TGF beta antibody instillation. - To
assess biologic response measurements of TGF beta blockade from serum tests and from pleural
fluid or biopsy tissue if this is available.
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