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| Name | Class |
|---|---|
| YUKIGUNI COMPANY | UNKNOWN |
| Weill Medical College of Cornell University | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maitake | Experimental | This is a phase II trial examining hematopoietic response in MDS patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
HEALTHY CONTROL ELIGIBILTY CRITERIA
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Wesa, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maitake | This is a phase II trial examining hematopoietic response in Myelodisplastic Patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Maitake | This is a phase II trial examining hematopoietic response in Myelodisplastic Patients. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | cells/mm^3 | baseline and week 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maitake | This is a phase II trial examining hematopoietic response in Myelodisplastic Patients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barrie Cassileth | Memorial Sloan Kettering Cancer Center | 646-888-0801 | Cassileth@mskcc.org |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| 1 |
| 21 |
| 21 |
| 21 |
| Aphonia | General disorders | CTC-4.0 | Systematic Assessment |
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| Confusion | Nervous system disorders | CTC-4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
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| Edema cerebral | Nervous system disorders | CTC-4.0 | Systematic Assessment |
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| Eye disorders - Other | Eye disorders | CTC-4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | CTC-4.0 | Systematic Assessment |
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| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | CTC-4.0 | Systematic Assessment |
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| Platelet count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTC-4.0 | Systematic Assessment |
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| Stroke | Nervous system disorders | CTC-4.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
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| Headache | General disorders | CTC-4.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Neutrophil count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| Pain in extremity | General disorders | CTC-4.0 | Systematic Assessment |
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| Platelet count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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| White blood cell decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
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