Status:
WITHDRAWN
Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 cel...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00903214
Start Date
May 1 2009
End Date
June 1 2011
Last Update
April 29 2013
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