Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

• Status: Terminated
• Trial end date: 2008-11-01
• 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 early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Riluzole

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed melanoma

• Stage III or IV disease

• Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy

• Must be eligible for resection of disease with curative or palliative intent

PATIENT CHARACTERISTICS:

• ECOG performance status 0 or 1

• ANC ≥ 1,000/mm³

• Platelet count ≥ 50,000/mm³

• AST/ALT ≤ 3 times upper limit of normal (ULN)

• Total bilirubin normal

• Calculated creatinine clearance ≥ 50 mL/min

• INR ≤ 25% of ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 48 hours after completion of study treatment

• No history of allergic reaction to riluzole or similar compounds

• No known history of hepatitis B or C

PRIOR CONCURRENT THERAPY:

• Not specified