Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Phase 2

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: Maitake

• Registration Number: NCT01099917
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-12-28
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Results First Posted: 2016-05-19
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maitake	Maitake	This is a phase II trial examining hematopoietic response in MDS patients.

Primary Outcome Measures

Name	Time	Method
Changes in Neutrophil Counts	baseline and week 12	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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States