Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Acral Lentiginous Malignant Melanoma, Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

In brief

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. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00470470

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2007-04-01

Expected to finish

2014-10-01

Last updated by the study team

2014-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed inoperable stage III or IV melanoma that began on acral skin or mucosa
• Patients with cutaneous melanoma that began on sun exposed sites of the skin and whose pathology demonstrates signs of sun damage (solar elastosis) involving the skin surrounding their primary melanoma are eligible
• Must have sufficient tumor tissue available for FISH and DNA sequencing
• Patients must have either a true amplification of 4q12 or a detectable mutation of c-KIT
• If no banked tumor tissue is available, or if the available banked tumor tissue is insufficient for the necessary testing, then a repeat biopsy procedure will be required to collect the necessary tumor sample
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• No known untreated brain or epidural metastases
• Brain metastases that have been treated and deemed stable are allowed
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy greater than 3 months
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Patients with unexplained hyperbilirubinemia that is clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert's syndrome) may be eligible
• AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
• Creatinine ≤ 1.5 times ULN
• PT and PTT ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception before and during study participation
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to imatinib mesylate
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure

Where it is running

• University of California at Los Angeles (UCLA ) — Los Angeles, California, United States
• Mount Sinai Medical Center CCOP — Miami Beach, Florida, United States
• Good Samaritan Medical Center — West Palm Beach, Florida, United States
• Palm Beach Cancer Institute-Main Office — West Palm Beach, Florida, United States
• New York University Langone Medical Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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