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

NCT00866840 | Completed Phase 2 Results

• 4 other identifiers: 0220080280P30CA072720CINJ-090802CDR0000637646
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With at Least One Adverse Event

  From date of randomization through completion of follow-up, up to three years

• Overall Survival

  Overall survival at one year

Study Arms (1)

Riluzole

EXPERIMENTAL

100 mg orally twice daily

Drug: riluzole

Interventions

riluzole DRUG

100 mg orally twice daily

Riluzole

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Related 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 melanoma. Pigment Cell Melanoma Res. 2018 Jul;31(4):534-540. doi: 10.1111/pcmr.12694. Epub 2018 Apr 10.

  PMID: 29453787 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: James Goydos, MD
• Organization: Rutgers Cancer Institute of New Jersey

goydosjs@cinj.rutgers.edu

(732) 235-7593

Study Officials

• James S. Goydos, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 19, 2024
• Results First Posted: September 28, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)