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

This study is ongoing, but not recruiting participants.

First Received on March 20, 2009. Last Updated on October 12, 2011 History of Changes

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	University of Medicine and Dentistry New Jersey
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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Riluzole

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry 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 ]

Estimated Enrollment:	27
Study Start Date:	April 2009
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

University of Medicine and Dentistry New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

James S. Goydos, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Medicine and Dentistry 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:	October 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Riluzole
Excitatory Amino Acid Antagonists

Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012