Coriolus Versicolor Extract in Treating Women With Stage I, Stage II, or Stage III Breast Cancer Who Have Finished Radiation Therapy - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00680667

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Dietary Supplement: Coriolus versicolor extract Other: flow cytometry Other: immunoenzyme technique Other: laboratory biomarker analysis	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of life as measured by the Functional Assessment of Cancer Therapy-for Patients With Breast Cancer v4.0 [ Designated as safety issue: No ]
Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue v4.0 and [ Designated as safety issue: No ]
Toxicity as assessed by the NCI CTCAE v3.0 and the Symptom Assessment questionnaire completed weekly during study and once at the 3-week follow-up visit [ Designated as safety issue: No ]
Percent change in NK cell activity associated with coriolus versicolor extract [ Designated as safety issue: No ]
Preliminary data that compare baseline and post-treatment immunologic measures including differential blood counts, natural killer cell activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset assays, and PBMC production of l ... [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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, 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

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of infiltrating ductal adenocarcinoma of the breast
- Stage I-III disease
Must meet all of the following criteria:
- Diagnosed within the past 12 months
- Has undergone surgery and chemotherapy
- Able to begin study treatment within 5 days after the last dose of radiotherapy
Estrogen and/or progesterone receptor-negative tumor

PATIENT CHARACTERISTICS:

Menopausal status not specified
WBC ≥ 2,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 20% times upper limit of normal (ULN)
Creatinine ≤ 20% times ULN
Alkaline phosphatase ≤ 20% times ULN
AST and ALT ≤ 20% times ULN
Albumin ≥ 3.0 g/dL
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
Willing to eat a consistent diet throughout the study and avoid dietary sources of mushrooms
No known allergy to fungi, including mushrooms
No 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

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior hematopoietic growth factors (e.g., Neupogen™, Epogen™)
Willing to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
Willing to avoid taking products containing coriolus versicolor extract, other immune modulating medicinal mushrooms, or other herbal products believed to have immune-modulating effects during radiotherapy and until completion of the last study visit
Willing to discontinue excluded medications and supplements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680667

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620
United States, Washington
Bastyr University	Recruiting
Kenmore, Washington, United States, 98028-4966
Contact: Leanna J. Standish, ND, PhD, MSAOM 425-823-1300

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Carolyn Torkelson, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000595754, UMN-2007LS019, UMN-IRB-0611M96168
Study First Received:	May 18, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00680667 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Estrogens
Progesterone
Skin Diseases
Breast Neoplasms

Carcinoma, Ductal, Breast
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009