NCT00667901

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

Enrollment Period

1.7 years

First QC Date

April 25, 2008

Last Update Submit

December 10, 2009

Conditions

Melanoma (Skin)

Keywords

stage III melanomastage IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Measurement of the inhibition of components of the Grm1 signaling cascade

Secondary Outcomes (1)

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

Interventions

riluzoleDRUG
protein expression analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
western blottingGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
pharmacological studyOTHER
neoadjuvant therapyPROCEDURE
therapeutic conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

RiluzoleReverse Transcriptase Polymerase Chain ReactionBlotting, WesternImmunohistochemistryNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesCombined Modality TherapyTherapeutics

Study Officials

  • James S. Goydos, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 28, 2008

Study Start

February 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

December 11, 2009

Record last verified: 2009-12

Locations

US(1)