Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

NCT01099917 | Completed Phase 2 Results

• 1 other identifier: 09-094
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome

Keywords

MDS; Maitake; mushroom; 09-094

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Maitake

EXPERIMENTAL

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

Drug: Maitake

Interventions

Maitake DRUG

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.

Maitake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Age ≥55 years
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• YUKIGUNI COMPANY: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Barrie Cassileth
• Organization: Memorial Sloan Kettering Cancer Center

Cassileth@mskcc.org

646-888-0801

Study Officials

• Kathleen Wesa, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 8, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 19, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-04

Locations

US (1)