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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
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: riluzole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Tumor shrinkage, as measured by RECIST criteria [ Time Frame: Treatment start date to date of best response ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: April 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riluzole
100 mg orally twice daily
Drug: riluzole
100 mg orally twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866840

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: James S. Goydos, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00866840     History of Changes
Other Study ID Numbers: CDR0000637646, P30CA072720, CINJ-090802
Study First Received: March 20, 2009
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Riluzole
Anticonvulsants
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014