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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Riluzole

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