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

Sponsor:	City of Hope Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	City of Hope Medical Center
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: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Other: gas chromatography-mass spectrometry Other: pharmacological study	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 City of Hope Medical Center:

Primary Outcome Measures:

Feasibility and toxicity of this regimen at six different dose levels [ Time Frame: 1 year after treatment on study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect on testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells [ Time Frame: 1 year after treatment on study ] [ Designated as safety issue: No ]
Effect on PSA kinetics [ Time Frame: 1 year after treatment on study ] [ 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)

Intervention Details:

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.

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.

Testing will be performed on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.

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.

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.

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.

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, 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.

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 prostatectomy, 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
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

City of Hope Medical Center

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 Medical Center
ClinicalTrials.gov Identifier:	NCT00779168 History of Changes
Other Study ID Numbers:	08012, P30CA033572, CHNMC-08012, CDR0000617012
Study First Received:	October 23, 2008
Last Updated:	October 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

recurrent prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012