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

Phase 1

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT00903214
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: