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

Primary Purpose

Melanoma (Skin)

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
riluzole
protein expression analysis
reverse transcriptase-polymerase chain reaction
western blotting
immunohistochemistry staining method
laboratory biomarker analysis
pharmacological study
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Outcomes

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)

Full Information

First Posted
April 25, 2008
Last Updated
December 10, 2009
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00667901
Brief Title
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
Official Title
A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
All enrollment, treatment, follow-up & data analysis completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
riluzole
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
western blotting
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Measurement of the inhibition of components of the Grm1 signaling cascade
Secondary Outcome Measure Information:
Title
Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S. Goydos, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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