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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00509041 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: dasatinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma |
| Enrollment: | 46 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dasatinib
Use of dasatinib in treatment of pts with previously treated malignant mesothelioma
|
Drug: dasatinib
50 mg PO bid
|
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant mesothelioma of any of the following subtypes:
Any site of origin of malignant mesothelioma allowed including, but not limited to, any of the following:
Measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT scan , MRI, or x-ray) or as ≥ 10 mm with spiral CT scan
Lesions that are considered nonmeasurable include the following:
Prior treatment with one and only one systemic chemotherapy regimen, which must have included pemetrexed disodium required
No symptomatic pleural effusions, unless the patient undergoes a therapeutic thoracentesis
PATIENT CHARACTERISTICS:
No significant cardiac disease, including any of the following:
No history of significant bleeding disorder unrelated to cancer, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiation therapy
Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
At least 7 days since prior and no concurrent antithrombotic or anti-platelet agents, including any of the following:
Warfarin
Heparin or low molecular weight heparin
At least 7 days since prior and no concurrent use of the following drugs:
Contacts and Locations
Show 37 Study Locations| Study Chair: | Arkadiusz Dudek, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00509041 History of Changes |
| Other Study ID Numbers: | CDR0000558362, U10CA031946, CALGB-30601 |
| Study First Received: | July 30, 2007 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Federal Government |
|
advanced malignant mesothelioma epithelial mesothelioma recurrent malignant mesothelioma sarcomatous mesothelioma |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |