Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Study Overview
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Brief Summary
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Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e). Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.

Official Title
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Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial

Conditions
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Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: Maitake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MSKCC patients age 18 or older able to sign informed consent Absolute Neutrophil count >0.5 K/mcL Diagnosis of MDS by bone marrow biopsy Patient not a candidate for aggressive standard treatment Exclusion Criteria: IPSS (High risk) History of AML History of Stem Cell transplant Known history of HIV+ Allergy to mushrooms Bone Marrow blasts >10% HEALTHY CONTROL ELIGIBILTY CRITERIA Inclusion Criteria Age ≥55 years Exclusion Criteria Currently taking corticosteroids or other immunosuppressants Known history of HIV+ Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maitake<br>This is a phase II trial examining hematopoietic response in MDS patients. | Drug: Maitake<br>* Patients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol. Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neutrophil Counts | The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients | baseline and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, Maitake, mushroom, 09-094