A Phase Ib of Mushroom Powder in Biochemically Recurrent Prostate Cancer
- To assess the feasibility and toxicity of prolonged white button mushroom extract at
six different dose levels in patients with biochemically recurrent prostate cancer
after local therapy.
- To analyze the effect of this regimen on a variety of biomarkers including
testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase,
parameters of immune function, and circulating tumor cells.
- To assess the effect of this regimen on PSA kinetics as a measure of disease activity
in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral white button mushroom extract twice daily on days 1-28. Courses repeat
every 4 weeks for up to 1 year in the absence of disease progression or unacceptable
Blood and urine samples are collected periodically for pharmacokinetic, pharmacodynamic, and
immunologic correlative studies. Plasma and urine samples are analyzed for quantification of
conjugated unsaturated fatty acids via gas chromatography-mass spectometry. Plasma samples
are analyzed for inhibition of aromatase via aromatase activity analysis and the effect of
treatment on immune cytokines levels via immunobiologic assays. Peripheral blood mononuclear
cells are analyzed for the effect of treatment on immune cell subsets and NK cell function
via multi-parameter flow cytometry; effect of treatment on NK cell activation status via
staining method; and measurement of circulating tumor cells via fluorescence microscopy,
fiber-optic array scanning technology (FAST), or high-speed flow cytometry. Additional serum
samples are collected for future studies.
Patients complete a diary listing days of administration of treatment and side effects.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and toxicity of this regimen at six different dose levels
1 year after treatment on study
Przemyslaw W. Twardowski, MD
Beckman Research Institute
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|