White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy - Full Text View

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00779168

Purpose

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 Other: chromatography Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Other: mass spectrometry Other: pharmacological study Other: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility and toxicity of this regimen at six different dose levels [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect on testosterone, dihydrotestosterone, dihydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells [ Designated as safety issue: No ]
Effect on PSA kinetics [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the feasibility and toxicity of prolonged white button mushroom extract at six different dose levels in patients with biochemically recurrent, hormone-naive prostate cancer after local therapy.

Secondary

To analyze the effect of this regimen on a variety of biomarkers including testosterone, dihydrotestosterone, dihydroepiandrosterone, 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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Biochemically recurrent disease
- PSA failure defined as PSA ≥ 0.2 ng/mL that has increased above nadir following prostatectomy OR PSA increase of 2.0 ng/mL above nadir following primary therapy with radiotherapy or other local therapy
- Increasing PSA value based on 2 consecutive measurements separated by ≥ 2 weeks AND no clinical or radiographic evidence of metastatic disease
Must have undergone at least 3 PSA measurements over a minimum of 3 months
No metastatic disease confirmed by bone scan and CT scan of the chest, abdomen, and pelvis within the past 2 months
Hormone-naive disease

PATIENT CHARACTERISTICS:

Performance status 0-2
Life expectancy > 3 months
WBC ≥ 2,000/mm^3
Platelet count ≥ 50,000/mm^3
Serum creatinine ≤ 2.5 mg/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT and SGPT ≤ 2.5 times ULN
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
No known allergy to mushrooms

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Any number of prior therapies (i.e., radical prostectomy, external beam radiotherapy, radioactive seed implantation, or cryotherapy) allowed
No prior cytotoxic chemotherapy or androgen ablative therapy for this disease
No adjuvant or neoadjuvant chemotherapy within the past 6 months
No more than 9 months of neoadjuvant or adjuvant hormone ablation in conjunction with primary definitive therapy (androgen deprivation must have been completed ≥ 6 months prior and testosterone level must be > 50)
No concurrent biological response modifiers or corticosteroids
No concurrent complimentary or alternative therapy (e.g., St. John's wort, PC-SPES, or other herbal remedies taken for the purpose of treating prostate cancer)
No concurrent antioxidant supplements (i.e., vitamin C or E)
No other concurrent chemotherapy or hormone ablative agents including steroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779168

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Maribel Junqueira, RN 800-826-4673

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Przemyslaw W. Twardowski, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00779168 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on March 11, 2010