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

NCT ID: NCT00903214

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-06-30

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.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the effects of glutamate receptor blockade with riluzole on cellular pathways important in the genesis and progression of disease in women with stage I-IIIA breast cancer by examining components of the mGluR1 signaling pathway in the pre- and post-treatment tumor samples to determine if glutamate blockade affects signaling through this pathway.

Secondary

• To determine whether treatment with riluzole affects the proliferation and apoptosis in a manner suggesting a potential for therapeutic effectiveness.
• To determine whether treatment with riluzole causes objectively measurable tumor shrinkage.

OUTLINE: Patients receive oral riluzole twice daily on days -14 to 0. Approximately 12 hours after completion of riluzole therapy patients undergo standard surgery (i.e., partial or total mastectomy) along with sentinel lymph node biopsy (for patients with node-negative disease) or full axillary dissection (for patients with node-positive disease) on day 0.

Patients undergo 3-dimensional image assessment at pre- and post-treatment by Computerized Ultrasound Risk Evaluation (C.U.R.E.).

Patients undergo core needle biopsy at baseline and during surgery for biomarker analysis (e.g., mGluR1) by IHC, western blotting, and RT-PCR. Blood samples are collected for GRM1 polymorphism analysis.

After completion of study treatment, patients are followed every 6 months for 1 year and then according to standard-of-care thereafter.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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)

Intervention Type: DRUG

polymorphism analysis

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

Intervention Type: GENETIC

axillary lymph node biopsy

Intervention Type: PROCEDURE

digital image analysis

Intervention Type: PROCEDURE

needle biopsy

Intervention Type: PROCEDURE

sentinel lymph node biopsy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Other Intervention Names

RILUTEK

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H. Gorski, MD, PhD, FACSw

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2008-120

Identifier Type: -

Identifier Source: secondary_id

CDR0000641180

Identifier Type: -

Identifier Source: org_study_id