Status:
COMPLETED
White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
Brief Summary
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 mushroo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00779168
Start Date
January 29 2009
End Date
June 10 2021
Last Update
March 31 2022
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000
2
South Pasadena Cancer Center
South Pasadena, California, United States, 91030