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

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

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.

OBJECTIVES:

Primary

• 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.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant melanoma

  • 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