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

• Status: Withdrawn
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Riluzole

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