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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00866840
First received: March 20, 2009
Last updated: November 18, 2013
Last verified: November 2013

March 20, 2009
November 18, 2013
April 2009
July 2013   (final data collection date for primary outcome measure)
Tumor shrinkage, as measured by RECIST criteria [ Time Frame: Treatment start date to date of best response ] [ Designated as safety issue: No ]
Tumor shrinkage, as measured by RECIST criteria [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00866840 on ClinicalTrials.gov Archive Site
  • Long-term toxicity of riluzole, as measured by NCI CTCAE version 3.0 [ Time Frame: Treatment start date through follow-up ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: Treatment start date to date of death ] [ Designated as safety issue: No ]
  • Long-term toxicity of riluzole, as measured by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Drug: riluzole
100 mg orally twice daily
Experimental: Riluzole
100 mg orally twice daily
Intervention: Drug: riluzole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00866840
CDR0000637646, P30CA072720, CINJ-090802
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: James S. Goydos, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP