RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.
Secondary
Determine the long-term toxicity of riluzole when administered to these patients. Compare the survival of these patients with historical controls.
OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Unresectable stage III or stage IV disease Measurable disease according to RECIST criteria, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan No known brain metastases unless treated and stable for ≥ 2 weeks by MRI evaluation
PATIENT CHARACTERISTICS:
ECOG performance status 0-2 ANC ≥ 1,000/μL Platelet count ≥ 50,000/μL Total bilirubin ≤ 2 times upper limit of normal (ULN) AST/ALT ≤ 3 times ULN INR ≤ 1.5 times ULN Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment No second primary malignancy, except carcinoma in situ of the cervix, adequately treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago with no evidence of recurrence No concurrent serious systemic disorders (including active infections) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study No history of allergic reactions attributed to riluzole No known history of hepatitis B or C
PRIOR CONCURRENT THERAPY:
No more than 1 prior therapeutic chemotherapy regimen for advanced melanoma Prior treatment with riluzole on clinical trial CINJ-090603 allowed No other concurrent investigational or commercial agents or therapies for the treatment of the malignancy
