White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy
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.
|Prostate Cancer||Drug: white button mushroom extract Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Other: gas chromatography-mass spectrometry Other: pharmacological study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase Ib Trial of Mushroom Powder in Biochemically Recurrent Prostate Cancer|
- Feasibility and toxicity of this regimen at six different dose levels [ Time Frame: 1 year after treatment on study ]
- Effect on testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells [ Time Frame: 1 year after treatment on study ]
- Effect on PSA kinetics [ Time Frame: 1 year after treatment on study ]
|Actual Study Start Date:||September 26, 2008|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive white button mushroom extract PO twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: white button mushroom extract
For this dose escalation study 6 patients will be treated at each of the following dosages: 4 grams PO daily, 6 grams PO daily, 8 grams PO daily, 10 grams PO daily, 12 grams PO daily and 14 grams PO daily.Other: flow cytometry
Immune cell subset number will be evaluated by flow cytometry on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.Other: immunologic technique
Testing will be performed on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.Other: laboratory biomarker analysis
Performed on blood samples collected pre-study (within 4 weeks of registration) and during weeks 3, 5, 9, 13, every 4 weeks beyond week 13 and at off study.Other: gas chromatography-mass spectrometry
Gas Chromatography-Mass Spectrometry (GC-MS) will be used to evaluate C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.Other: pharmacological study
Evaluation of C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779168
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|Principal Investigator:||Przemyslaw W. Twardowski, MD||City of Hope Medical Center|