NCT00509041

Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	dasatinib	50 mg PO bid

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-02-01
• Completion: 2012-12-01
• First posted: 2007-07-31
• Last updated: 2016-08-11
• Results posted: 2013-01-17

Locations

37 sites across 1 country: United States