PhaseI/II Trial of Trametes Versicolor in Breast Cancer Patients

Extracts of the medical mushroom Trametes versicolor (Tv) are prescribed as adjunctive immune therapy for women with breast cancer in both Asia and by licensed North American naturopathic physicians. Japanese data suggest that Tv may improve survival and reduce recurrence in early stage breast cancer. While Tv is prescribed by NDs and other CAM practitioners and used with growing frequency among breast cancer patients as an over-the-counter supplement there have yet to be well-designed clinical studies in the United States. Standardized commercially available products are in wide use.

The phase I/II clinical trial of orally administered Tv is the first U.S. trial of this promising CAM adjunctive immunomodulatory cancer therapy.

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Trametes Versicolor-Induced Immunopotentiation in Vivo/Ex Vivo

Mushroom products advertised as immune-enhancing agents are readily available over the counter and prescribed by licensed Naturopathic and traditional Chinese medicine practitioners in North America for cancer care. While prescription of purified mushroom actives is common, complex mushroom extracts are gaining popularity in the CAM community based on the assumption that synergy between multiple active constituents in a more complex formula enhances clinical efficacy. Well-characterized Trametes versicolor (Tv) extracts, polysaccharide-Krestin (PSK) and polysaccharopeptide (PSP), are approved drugs for cancer adjunctive immunotherapy in Asia. Many published in vitro, animal and clinical studies, most conducted in Japan or China, report immune-enhancing properties of these Β-glucan-containing protein-polysaccharide fractions that potentiate antitumor activities of neutrophils, monocytes, macrophages, NK cells and T cells. Additionally, a large body of evidence suggests purified Β-glucans isolated from fungi, yeast and cereal grains induce potent antitumor immune responses.

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Trametes Versicolor-Induced Immunopotentiation in Murine Model

A number of commercially-obtained derivatives of the mushroom Trametes Versicolor (Tv) have been shown to activate the immune system in rodent models. These derivatives contain high levels of ß-glucans, which interact with a number of immune-related cell types. Subsequent industry-sponsored research into the mechanism of these products has resulted in a dearth of research into the parental whole product that contains a number of potentially immunopotentiating constituents including ergosterol-like compounds. At this juncture, the potential for synergistic action between the ß-glucan polysaccharides and the non-glucan constituents have not been investigated. Furthermore, the direct connection between quantity of TV crude extract consumption, induction of an immune response, and tumor regression/amelioration of treatment side effects remains to be explored.

We hypothesize that ß-glucan polysaccharides in Tv represent a major constituent that, when consumed orally in a murine tumor system, upregulate the immune system causing tumor regression and amelioration of therapy-induced side effects. Furthermore, we theorize that non-glucan constituents can have an additive or even synergistic effect on the stimulation of the immune response.

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Data Core

The DCRC Data Core (DC) serves as the Center’s resource for providing Data Management, Data Quality Assurance, Data Processing, and Statistical Analysis for the DCRC.  The DC is housed at Bastyr University under the direction of Annette Fitzpatrick Ph.D. who works closely with the Director of the Administrative Core and the other DCRC project leaders in ensuring that all clinical data collection, management and analysis processes are of the highest quality.

The DC develops and implements Standard Operating Procedures for all data collection and management activities and provides quality assurance and control activities.  The DC also supports Dr. Standish in developing a Data Safety Monitoring Plan for the Dose Escalation trial planned for Project 3.

Data for reports to the Administrative Core, Internal and External Advisory Committees, the IRBs of the participating institutions and NCCAM is the responsibility of the DC.  Analysis of data for publications and future grant applications will also be conducted by the DC.  Both the DCRC and its component projects benefit from the services provided by the DC from project initiation with the development of data collection tools and study databases through project completion with reports to be used in manuscript development and future study designs.

Key Personnel:
Annette Fitzpatrick, Director, Bastyr University

Bioanalytical Core

The Bioanalytical Core serves a four-fold function within the DCRC:

1. Core facility for assessing levels of immunopotentiating bioactive components of Trametes versicolor (Tv) and in tissues and serum provided by the three Projects.
2. Storage and distribution facility for the Tv extracts and control test compounds to all of the projects.
3. Central facility for ß-glucan fractionation, enzymatic degradation, and labeling.
4. Training facility to learn botanical bioanalysis.

The Core is located at the University of Minnesota and lead by Rory Remmel, PhD. Dr. Remmel oversees all analyses performed within the Core. The extracts are from Paul Stamets and Fungi Perfecti and chain of custody is maintained on all test products and stability is assessed at regular intervals. Gary Ostroff, PhD, an internationally recognized leader in ß-glucan research serves as a consultant working with the Bioanalytical Core to a) fractionate, isolate and purify ß-glucan fractions from complex Tv extracts; b) enzymatically degrade ß-glucans in Tv to create a test compound for use in Projects 1 and 2; and c) create a fluorescently labeled purified beta-glucan for use in biodistribution studies.

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