A Phase 1 interventional study of riluzole and polymorphism analysis in Breast Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-29.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and 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
Secondary
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the breast
Stage I (T1c)-IIIA disease meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
100 mg orally twice a day, tablets self-administered, administered from day -14 to day 0 (scheduled surgery and preserve tissue for biormarker analysis)
Also known as: RILUTEK
Pre-treatment, day -15 but may be done any time after enrollment but before 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:
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Barbara Ann Karmanos Cancer Institute