Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

December 10, 2009 updated by: University of Medicine and Dentistry of New Jersey

A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma

RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.

PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
  • To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.

Secondary

  • Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.

OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.

Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.

PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed melanoma

    • Stage III or IV disease
  • Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy
  • Must be eligible for resection of disease with curative or palliative intent

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 50,000/mm³
  • AST/ALT ≤ 3 times upper limit of normal (ULN)
  • Total bilirubin normal
  • Calculated creatinine clearance ≥ 50 mL/min
  • INR ≤ 25% of ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 48 hours after completion of study treatment
  • No history of allergic reaction to riluzole or similar compounds
  • No known history of hepatitis B or C

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measurement of the inhibition of components of the Grm1 signaling cascade

Secondary Outcome Measures

Outcome Measure
Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (ESTIMATE)

April 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000592958
  • P30CA072720 (U.S. NIH Grant/Contract)
  • CINJ-090603
  • CINJ-IRB-0220060225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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