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

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Drug: riluzole

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Riluzole; 100 mg orally twice daily	Drug: riluzole; 100 mg orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response as Measured by RECIST Criteria	Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.	Imaging for tumor assessments was performed after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least One Adverse Event	Adverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0.	From date of randomization through completion of follow-up, up to three years
Overall Survival	Kaplan-Meier plots of probability of overall survival.	Overall survival at one year

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: James S. Goydos, MD, Rutgers Cancer Institute of New Jersey

Publications and helpful links

General Publications

• Mehnert JM, Silk AW, Lee JH, Dudek L, Jeong BS, Li J, Schenkel JM, Sadimin E, Kane M, Lin H, Shih WJ, Zloza A, Chen S, Goydos JS. A phase II trial of riluzole, an antagonist of metabotropic glutamate receptor 1 (GRM1) signaling, in patients with advanced melanoma. Pigment Cell Melanoma Res. 2018 Jul;31(4):534-540. doi: 10.1111/pcmr.12694. Epub 2018 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimated): March 23, 2009

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: recurrent melanoma; stage IV melanoma; stage III melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neuroprotective Agents; Protective Agents; Anticonvulsants; Riluzole
• Other Study ID Numbers: 0220080280; P30CA072720 (U.S. NIH Grant/Contract); CINJ-090802 (Other Identifier: CINJ); CDR0000637646 (Other Identifier: CDR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO