NCT00903214

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

Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-05-18
• Last updated: 2013-04-29