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Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2009
First Received: March 20, 2009   Last Updated: April 7, 2009   History of Changes
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00866840
  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 II

MedlinePlus related topics: Cancer Melanoma Surgery
Drug Information available for: Riluzole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor shrinkage, as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term toxicity of riluzole, as measured by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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
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 Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: James S. Goydos, MD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( James S. Goydos )
Study ID Numbers: CDR0000637646, CINJ-090802
Study First Received: March 20, 2009
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00866840     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Riluzole
Excitatory Amino Acids
Neurotransmitter Agents
Neuroprotective Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Anticonvulsants

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

ClinicalTrials.gov processed this record on May 07, 2009