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

This study has been terminated.
(All enrollment, treatment, follow-up & data analysis completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667901
First Posted: April 28, 2008
Last Update Posted: December 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin) Drug: riluzole Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Genetic: western blotting Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measurement of the inhibition of components of the Grm1 signaling cascade

Secondary Outcome Measures:
  • Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)

Estimated Enrollment: 15
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667901


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 of New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: James S. Goydos, MD Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: James Goydos, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00667901     History of Changes
Other Study ID Numbers: CDR0000592958
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-090603
CINJ-IRB-0220060225
First Submitted: April 25, 2008
First Posted: April 28, 2008
Last Update Posted: December 11, 2009
Last Verified: December 2009

Keywords provided by Rutgers, The State University of New Jersey:
stage III melanoma
stage IV 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
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents