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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00470470 |
Purpose
RATIONALE: Imatinib mesylate 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 imatinib mesylate works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: imatinib mesylate Genetic: comparative genomic hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Imatinib Mesylate (STI571;NSC#716051:IND 61135) in Patients With Inoperable AJCC Stage III or IV Melanoma Harboring Somatic Alterations of C-KIT |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to true amplification of c-KIT by FISH vs mutations by DNA sequencing.
Patients receive oral imatinib mesylate twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples or unstained tissue slides/paraffin blocks may be collected. c-KIT is evaluated by IHC and comparative genomic hybridization.
After completion of study treatment, patients are followed up periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed inoperable stage III or IV melanoma that began on acral skin or mucosa
Must have sufficient tumor tissue available for FISH and DNA sequencing
No known untreated brain or epidural metastases
PATIENT CHARACTERISTICS:
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent inhibitors of CYP3A4, including any of the following:
Herbal extracts and tinctures with CYP3A4 inhibitory activity, including the following:
No concurrent inducers of CYP3A4, including any of the following:
Contacts and Locations| United States, California | |
| University of California Los Angeles Medical Center | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Bartosz Chmielowski, MD 310-206-1214 | |
| United States, Florida | |
| Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Jose Lutzky, MD 305-535-3305 | |
| Palm Beach Cancer Institute - West Palm Beach | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Neal E. Rothschild, MD 561-366-4131 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Richard Carvajal, MD 212-639-5096 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Howard L. Kaufman, MD 212-241-4757 | |
| New York Presbyterian Hospital-Cornell Medical Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Tsiporah B. Shore, MD, FRCP, FACP 212-746-2646 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Anna Pavlick, MD 212-731-5431 anna.pavlick@nyumc.org | |
| Study Chair: | Richard Carvajal, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Paul B. Chapman, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | David Paul Kelsen, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00470470 History of Changes |
| Other Study ID Numbers: | CDR0000543404, MSKCC-07014 |
| Study First Received: | May 3, 2007 |
| Last Updated: | August 24, 2010 |
| Health Authority: | Unspecified |
|
recurrent melanoma stage IV melanoma acral lentiginous malignant melanoma |
stage IIIA melanoma stage IIIB melanoma stage IIIC melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |