A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Inclusion Criteria

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