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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00779168 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: white button mushroom extract Procedure: chromatography Procedure: flow cytometry Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: pharmacological study Procedure: staining method |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase Ib of Mushroom Powder in Biochemically Recurrent, Hormone Naive Prostate Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biochemically recurrent disease
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 |
Principal Investigator: | Przemyslaw W. Twardowski, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Przemyslaw W. Twardowski ) |
Study ID Numbers: | CDR0000617012, CHNMC-08012 |
Study First Received: | October 23, 2008 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00779168 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |