Melanoma Clinical Trial
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
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.
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.
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
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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New Brunswick New Jersey, 08903, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.