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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00779168
First received: October 23, 2008
Last updated: May 6, 2014
Last verified: May 2014
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib of Mushroom Powder in Biochemically Recurrent Prostate Cancer

Resource links provided by NLM:


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: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive white button mushroom extract PO twice daily on days 1-28. Treatment repeats every 4 weeks for up to 1 year 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.

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 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 for up to 1 year 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

Inclusion Criteria:

Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate

Patients must have a PSA failure defined as PSA of >= 0.2 ng/ml that has increased above nadir following prostatectomy

If radiation or other local therapy was used as a primary therapy and no prostatectomy was performed patients must have PSA increase of 2.0 above post-therapy nadir; PSA value must be increasing based on two consecutive measurements each separated by at least 2 weeks with no clinical or radiographic evidence of metastatic disease; PSA values that meet the criteria for eligibility within 4 weeks of registration are acceptable to document eligibility for enrollment on this study; PSA level obtained after registration and prior to the first course will be used as the "baseline" PSA as per the schema but will not determine eligibility for participation

Patients must have had at least three PSA measurements over a minimum of three months available prior to enrollment to this study

Patients may have received any number of local therapies (radical prostatectomy, external beam radiation therapy, radioactive seed implantation, cryotherapy)

Bone scan and computed tomography (CT) scan of the chest, abdomen and pelvis negative for metastatic disease within 2 months prior to registration

Patients must have a performance status of 0, 1, or 2

All patients will have malignancy confirmed by review of their biopsy specimens by the Division of Pathology, City of Hope National Medical Center; if no pathological specimen is available for review, the patient may still be included if the patient has clearly documented prostate cancer per pathology report and a specimen request is documented as having been made for tissue from the outside facility but a specimen was unable to be obtained

Serum creatinine =< 2.5 mg/dL

Baseline liver function tests including bilirubin =< 1.5 x the institutional upper limit of normal and serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =< 2.5 x the institutional upper limit of normal

White blood cells (WBC) >= 2000

Platelets >= 50,000

Exclusion Criteria:

Patients with evidence of metastatic disease PSA progression not verified by sequential rising PSA as discussed in the eligibility section

Patients who have received prior cytotoxic chemotherapy or androgen ablative therapy for recurrent disease

Patients currently receiving biological response modifiers, or corticosteroids

Patients are permitted to have received up to 24 months of neoadjuvant or adjuvant hormone ablation in conjunction with their primary definitive therapy; androgen deprivation must have been completed at least 6 months prior to registration and testosterone level must be > 50; no complementary or alternative therapy (e.g. St. John's Wort, PC-SPES, or other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment; patients are allowed to have received neoadjuvant and/or adjuvant chemotherapy that was completed at least 6 months prior to registration to the protocol

Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements

Patients with known allergy to mushrooms

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Przemyslaw W. Twardowski, MD Beckman Research Institute
  More Information

Additional Information:
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: May 6, 2014
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 September 18, 2014