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Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer

NCT00903214 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-04-29

No results posted yet for this study

Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells.

PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer.

Conditions

Interventions

DRUG

riluzole

100 mg orally twice a day, tablets self-administered, administered from day -14 to day 0 (scheduled surgery and preserve tissue for biormarker analysis)

GENETIC

polymorphism analysis

Pre-treatment, day -15 but may be done any time after enrollment but before surgery.

PROCEDURE

axillary lymph node biopsy

PROCEDURE

digital image analysis

PROCEDURE

needle biopsy

PROCEDURE

sentinel lymph node biopsy

PROCEDURE

therapeutic conventional surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • David H. Gorski, MD, PhD, FACSw · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903214 on ClinicalTrials.gov