Clinical trial NCT00680667: Clinical Trial of Trametes Versicolor in Women With Breast Cancer
Official title: Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: ductal breast carcinoma
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
estrogen receptor-negative breast cancer
progesterone receptor-negative breast cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-05-20
Enrollment: 11
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have finished radiation therapy.

Detailed description: OBJECTIVES:

Primary

* To determine the maximum tolerated dose of oral coriolus versicolor extract in women with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive (as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently completed standard post-surgery radiotherapy.

Secondary

* To determine the feasibility of measuring changes in fatigue and quality of life of patients treated with this drug.
* To characterize the toxicity of this drug in these patients.
* To gather preliminary data that compare baseline and post-treatment immunologic measures, including differential blood counts (i.e., WBC), natural killer cell activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset assays, peripheral blood mononuclear cell production of levels of interferon gamma, and tumor necrosis factor-alpha in these patients.

OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.

Patients undergo quality of life and fatigue assessment at baseline, weekly during study, and at the 3-week follow-up visit.

Blood samples are collected periodically for immunological marker studies. Samples are analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays, T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs are analyzed via standard enzyme-linked immunosorbent assay.

After completion of study treatment, patients are followed at 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
* Estrogen and/or progesterone receptor-negative or positive
* Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
* Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
* Adequate organ function within 14 days of study enrollment including the following:

  * Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
  * Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
  * Renal: Creatinine ≤ 20% times ULN
  * Nutritional status: Albumin ≥ 3.0 g/dL
* Negative pregnancy test
* Voluntary written consent before performance of any study-related procedure not part of the normal medical care

Exclusion Criteria:

* Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
* Known allergy to fungi, including mushrooms
* Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
* Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
* Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
* Unwilling to discontinue excluded medications and supplements

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: Up to 6 Weeks After Treatment
Secondary outcomes:
measure: Quality of life
timeFrame: Over 6 Weeks
measure: Fatigue
timeFrame: Over 6 Weeks
measure: Symptom Assessment
timeFrame: Weekly and at 3 Week Follow-Up
measure: NK cell activity
timeFrame: Over 6 weeks
measure: comparison of immunologic measures
timeFrame: Baseline and Post-Treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Carolyn Torkelson, MD
role: PRINCIPAL_INVESTIGATOR
References: