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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027586 |
Purpose
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for metastatic melanoma.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Gleevec (Imatinib Mesylate, STI-571) in Metastatic Melanoma |
| Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate (STI571) twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-78 patients will be accrued for this study within 6-15 months.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 20% of tumor cells with 1 of the following by immunohistochemistry:
At least 1 unidimensionally measurable metastatic target lesion, defined by 1 of the following:
No symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior interferon therapy and/or one other systemic therapy regimen (e.g., chemotherapy, biotherapy, or biochemotherapy) allowed
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Kevin Kim, MD | M.D. Anderson Cancer Center |
| Investigator: | Menashe Bar-Eli, PhD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000069045, MDA-ID-01284, NCI-5345 |
| Study First Received: | December 7, 2001 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027586 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Imatinib Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |