MedTrace Logo

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

NCT00779168 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-03-31

No results posted yet for this study

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 mushroom extract in treating patients with recurrent prostate cancer after local therapy.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Cy Stein, MD, PhD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-29
Primary Completion
2021-06-10
Completion
2021-06-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00779168 on ClinicalTrials.gov