White Button Mushroom Extract in Treating Patients With Recurrent Prostate

Status Completed

Clinical Trial Summary

RATIONALE: White button mushroom extract may stop or delay the development of recurrent prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in treating patients with recurrent prostate cancer after local therapy.

Clinical Trial Description

OBJECTIVES: Primary - To assess the feasibility and toxicity of prolonged white button mushroom extract therapy at six different dose levels in patients with biochemically recurrent prostate cancer after local therapy. Secondary - 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 in the absence of disease progression or unacceptable toxicity. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00779168
Study type	Interventional
Source	City of Hope Medical Center
Contact
Status	Completed
Phase	Phase 1
Start date	January 29, 2009
Completion date	June 10, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms