Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Yale University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436605 |
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 stage III melanoma that cannot be removed by surgery or stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of Dasatinib in Advanced Melanoma |
Estimated Enrollment: | 35 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No known brain metastases or leptomeningeal metastases
PATIENT CHARACTERISTICS:
No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:
No clinically significant cardiovascular disease, including any of the following:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
History of significant congenital or acquired bleeding disorder, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 1 week since prior and no concurrent steroids or other immunosuppressive agents
At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:
At least 4 weeks since prior radiotherapy
United States, Connecticut | |
Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06520-8028 | |
Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | Harriet Kluger, MD | Yale University |
Responsible Party: | Yale Cancer Center ( Harriet Kluger ) |
Study ID Numbers: | CDR0000528937, YALE-HIC-0608001765, UMN-2007UC009 |
Study First Received: | February 15, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00436605 History of Changes |
Health Authority: | Unspecified |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Dasatinib Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Protein Kinase Inhibitors Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Dasatinib Nevi and Melanomas |