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Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
This study is currently recruiting participants.
Study NCT00903214   Information provided by National Cancer Institute (NCI)
First Received: May 15, 2009   Last Updated: January 13, 2010   History of Changes

May 15, 2009
January 13, 2010
May 2009
April 2011   (final data collection date for primary outcome measure)
  • Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity [ Designated as safety issue: No ]
  • Downregulation of phosphorylated ERK1/2 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00903214 on ClinicalTrials.gov Archive Site
  • Measures of proliferation, specifically mitotic rate and expression of Ki-67 [ Designated as safety issue: No ]
  • Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity [ Designated as safety issue: No ]
Same as current
 
Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment

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.

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.

Phase I
Interventional
Masking:  Open Label
Primary Purpose:  Treatment
Breast Cancer
  • Drug: riluzole
  • Genetic: polymorphism analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Genetic: western blotting
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: axillary lymph node biopsy
  • Procedure: digital image analysis
  • Procedure: needle biopsy
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
15
 
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
 
United States
 
NCT00903214
David H. Gorski, Barbara Ann Karmanos Cancer Institute
CDR0000641180, WSU-2008-120
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigator: Amy Kranitz Barbara Ann Karmanos Cancer Institute
Principal Investigator: David H. Gorski, MD, PhD, FACSw Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP