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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey Identifier:
First received: March 20, 2009
Last updated: November 18, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Melanoma (Skin) Drug: riluzole Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Tumor shrinkage, as measured by RECIST criteria [ Time Frame: Treatment start date to date of best response ]

Secondary Outcome Measures:
  • Long-term toxicity of riluzole, as measured by NCI CTCAE version 3.0 [ Time Frame: Treatment start date through follow-up ]
  • Survival [ Time Frame: Treatment start date to date of death ]

Enrollment: 13
Study Start Date: April 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riluzole
100 mg orally twice daily
Drug: riluzole
100 mg orally twice daily

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  • 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


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00866840

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: James S. Goydos, MD Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT00866840     History of Changes
Other Study ID Numbers: CDR0000637646
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-090802 ( Other Identifier: CINJ )
Study First Received: March 20, 2009
Last Updated: November 18, 2013

Keywords provided by Rutgers, The State University of New Jersey:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents processed this record on September 21, 2017