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

Phase 2

Completed

• Conditions: Melanoma (Skin)
• Interventions: Drug: riluzole

• Registration Number: NCT00866840
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Study Start: 2009-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2017-03-06
• Results First Submitted QC: 2022-09-01
• Results First Posted: 2022-09-28
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Riluzole	riluzole	100 mg orally twice daily

Primary Outcome Measures

Name	Time	Method
Tumor Response as Measured by RECIST Criteria	Imaging for tumor assessments was performed after 6 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States