Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with
previously treated malignant mesothelioma.
OBJECTIVES:
Primary
- To determine the rate of progression-free survival (PFS) at 24 weeks (or 5.5 months) in
patients with malignant mesothelioma treated with dasatinib.
Secondary
- To determine the response rate (partial response [PR] and complete response [CR]) in
patients with malignant mesothelioma treated with dasatinib.
- To determine the response duration in patients with malignant mesothelioma treated with
dasatinib.
- To describe the overall survival (OS) of patients with malignant mesothelioma treated
with dasatinib.
- To describe the toxicity profile of dasatinib in patients with malignant mesothelioma.
- To determine whether the amount of expression of EphA2 and PDGFRβ, as measured by
immunohistochemistry from tumor specimens, correlates with PFS in patients with
malignant mesothelioma.
- To determine whether plasma levels of VEGF and PDGFRβ, serum levels of CSF-1, and
soluble mesothelin-related protein correlate with PFS in patients with malignant
mesothelioma.
- To determine whether inhibition of Src phosphorylation in PBMC correlates with PFS.
- To assess inhibition of phosphorylation of Src, EphA2, and PDGFRβ in tumor tissue by
dasatinib.
OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every
28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
studies. Tumor tissue samples are analyzed for EphA2 and PDGFRβ expression by
immunohistochemistry. Tumor tissue samples may also be analyzed for phosphorylation of Src,
EphA2, and PDGFRβ by western blot. Blood samples are analyzed for concentration of VEGF and
PDGF by quantitative sandwich enzyme immunoassay technique; mesothelin-related protein level
by Mesomark® assay; CSF-1 level by ELISA assay; and phosphorylation of Src by phospho-Src
(pTyr418) human ELISA.
After completion of study treatment, patients are followed at least every 2 months for 1
year, then every 4 months for 1 year, then every 6 months for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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