Myelodysplastic Syndrome
Conditions
Keywords
MDS, Maitake, mushroom, 09-094
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.
Interventions
DRUGMaitake
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.
Sponsors
YUKIGUNI COMPANY
Weill Medical College of Cornell University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Maitake This is a phase II trial examining hematopoietic response in Myelodisplastic Patients. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Not Treated | 24 |
Baseline characteristics
| Characteristic | Maitake |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
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
Time frame: baseline and week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maitake | Changes in Neutrophil Counts | -0.3 cells/mm^3 |