NCT00903214

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 breast-cancer

Status
withdrawn

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

May 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

May 15, 2009

Last Update Submit

April 25, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

  • Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity

    Pre and Post-treatment with RILUTEK® (riluzole) administration

  • Downregulation of phosphorylated ERK1/2

    Pre and Post treatment with RILUTEK® (riluzole) administration:

Secondary Outcomes (2)

  • Measures of proliferation, specifically mitotic rate and expression of Ki-67

    Pre and Post treatment with RILUTEK® (riluzole) administration:

  • Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity

    Pre and Post treatment with RILUTEK® (riluzole) administration:

Interventions

riluzoleDRUG

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

Also known as: RILUTEK
polymorphism analysisGENETIC

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

axillary lymph node biopsyPROCEDURE
digital image analysisPROCEDURE
needle biopsyPROCEDURE
sentinel lymph node biopsyPROCEDURE
therapeutic conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the breast * Stage I (T1c)-IIIA disease meeting the following criteria: * Large enough (\> 1 cm) to undergo additional multiple core needle biopsies preoperatively * Surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy * Patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * Liver function tests ≤ 3 times upper limit of normal (ULN) * Total bilirubin ≤ 2 times ULN * Creatinine ≤ 1.5 mg/dL * INR ≤ 25% normal limits * Not pregnant or nursing * No known history of HIV or AIDS * No known history of hepatitis B or C * No history of vertigo or Ménière's type of disorder * No history of allergic reaction to riluzole or similar compounds PRIOR CONCURRENT THERAPY: * No prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer

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

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RiluzoleAmplified Fragment Length Polymorphism AnalysisBiopsy, NeedleSentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesLymph Node Excision

Study Officials

  • David H. Gorski, MD, PhD, FACSw

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 29, 2013

Record last verified: 2013-04