Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00903214|
Recruitment Status : Withdrawn (Funding ended)
First Posted : May 18, 2009
Last Update Posted : April 29, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: riluzole Genetic: polymorphism analysis Procedure: axillary lymph node biopsy Procedure: digital image analysis Procedure: needle biopsy Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- 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)Other Name: RILUTEK
- 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
- Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity [ Time Frame: Pre and Post-treatment with RILUTEK® (riluzole) administration ]
- Downregulation of phosphorylated ERK1/2 [ Time Frame: Pre and Post treatment with RILUTEK® (riluzole) administration: ]
- Measures of proliferation, specifically mitotic rate and expression of Ki-67 [ Time Frame: Pre and Post treatment with RILUTEK® (riluzole) administration: ]
- Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity [ Time Frame: Pre and Post treatment with RILUTEK® (riluzole) administration: ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903214
|Principal Investigator:||David H. Gorski, MD, PhD, FACSw||Barbara Ann Karmanos Cancer Institute|
|Responsible Party:||Barbara Ann Karmanos Cancer Institute|
|Other Study ID Numbers:||
P30CA022453 ( U.S. NIH Grant/Contract )
|First Posted:||May 18, 2009 Key Record Dates|
|Last Update Posted:||April 29, 2013|
|Last Verified:||April 2013|
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Neoplasms by Site
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs