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

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

riluzole

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Riluzole

Arm Description

100 mg orally twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00866840

First Posted

March 20, 2009

Last Updated

September 1, 2022

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00866840

Brief Title

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

Official Title

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 2009 (Actual)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Riluzole

Arm Type

Experimental

Arm Description

100 mg orally twice daily

Intervention Type

Drug

Intervention Name(s)

riluzole

Intervention Description

100 mg orally twice daily

Primary Outcome Measure Information:

Title

Tumor Response as Measured by RECIST Criteria

Description

Time Frame

Imaging for tumor assessments was performed after 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James S. Goydos, MD

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29453787

Citation

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.

Results Reference

result

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

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