A Phase Ib Trial of Mushroom Powder in Biochemically Recurrent Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Feasibility and toxicity of this regimen at six different dose levels
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- 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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: white button mushroom extract (Drug)
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.
干预措施: flow cytometry (Other)
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.
干预措施: immunologic technique (Other)
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.
干预措施: laboratory biomarker analysis (Other)
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.
干预措施: gas chromatography-mass spectrometry (Other)
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.
干预措施: pharmacological study (Other)
结局指标
主要结局
Feasibility and toxicity of this regimen at six different dose levels
时间窗: 1 year after treatment on study
次要结局
- Effect on PSA kinetics(1 year after treatment on study)
- Effect on testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells(1 year after treatment on study)