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Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Maitake
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring MDS, Maitake, mushroom, 09-094

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maitake

Arm Description

This is a phase II trial examining hematopoietic response in MDS patients.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2010
Last Updated
April 11, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
YUKIGUNI COMPANY, Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01099917
Brief Title
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
Official Title
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
YUKIGUNI COMPANY, Weill Medical College of Cornell University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
MDS, Maitake, mushroom, 09-094

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maitake
Arm Type
Experimental
Arm Description
This is a phase II trial examining hematopoietic response in MDS patients.
Intervention Type
Drug
Intervention Name(s)
Maitake
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Neutrophil Counts
Description
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
Time Frame
baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Wesa, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

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Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

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