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

Barbara Ann Karmanos Cancer Institute

Status and phase: Withdrawn; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: needle biopsy; Procedure: therapeutic conventional surgery; Procedure: axillary lymph node biopsy; Procedure: sentinel lymph node biopsy; Genetic: polymorphism analysis; Procedure: digital image analysis; Drug: riluzole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00903214

P30CA022453 (U.S. NIH Grant/Contract)

CDR0000641180

WSU-2008-120

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)