Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
- To determine the maximum tolerated dose of oral coriolus versicolor extract in women
with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive
(as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently
completed standard post-surgery radiotherapy.
- To determine the feasibility of measuring changes in fatigue and quality of life of
patients treated with this drug.
- To characterize the toxicity of this drug in these patients.
- To gather preliminary data that compare baseline and post-treatment immunologic
measures, including differential blood counts (i.e., WBC), natural killer cell
activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset
assays, peripheral blood mononuclear cell production of levels of interferon gamma, and
tumor necrosis factor-alpha in these patients.
OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.
Patients undergo quality of life and fatigue assessment at baseline, weekly during study,
and at the 3-week follow-up visit.
Blood samples are collected periodically for immunological marker studies. Samples are
analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood
mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine
secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays,
T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production
of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs
are analyzed via standard enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed at 3 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Up to 6 Weeks After Treatment
Carolyn Torkelson, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|
|Bastyr University||Kenmore, Washington|