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Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2010
First Received: May 15, 2009   Last Updated: January 13, 2010   History of Changes
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00903214
  Purpose

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 Intervention Phase
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
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: May 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903214

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: David Gorski     313-576-8490        
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Investigator: Amy Kranitz Barbara Ann Karmanos Cancer Institute
Principal Investigator: David H. Gorski, MD, PhD, FACSw Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute ( David H. Gorski )
Study ID Numbers: CDR0000641180, WSU-2008-120
Study First Received: May 15, 2009
Last Updated: January 13, 2010
ClinicalTrials.gov Identifier: NCT00903214     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

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

ClinicalTrials.gov processed this record on February 08, 2010