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

Rutgers The State University of New Jersey

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Treatments

Drug: riluzole

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00866840

CDR0000637646

P30CA072720 (U.S. NIH Grant/Contract)

CINJ-090802 (Other Identifier)

0220080280

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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