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

Melanoma (Skin) Clinical Trial

Official title:

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866840
• Other study ID #: 0220080280
• Secondary ID: P30CA072720CINJ-
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: July 2013

Study information

• Verified date: December 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• riluzole
100 mg orally twice daily

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival	Kaplan-Meier plots of probability of overall survival.	Overall survival at one year