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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Recruitment Status : Withdrawn (Funding ended)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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

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 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

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Riluzole
U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity [ Time Frame: Pre and Post-treatment with RILUTEK® (riluzole) administration ]
  2. Downregulation of phosphorylated ERK1/2 [ Time Frame: Pre and Post treatment with RILUTEK® (riluzole) administration: ]

Secondary Outcome Measures :
  1. Measures of proliferation, specifically mitotic rate and expression of Ki-67 [ Time Frame: Pre and Post treatment with RILUTEK® (riluzole) administration: ]
  2. 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, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: David H. Gorski, MD, PhD, FACSw Barbara Ann Karmanos Cancer Institute

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00903214     History of Changes
Other Study ID Numbers: CDR0000641180
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2008-120
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents