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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-05059 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate mofetil may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewing's tumors.
OBJECTIVES:
OUTLINE: This is a prospective study.
After completion of study treatment, patients are followed periodically for at least 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo followed by DSCT | Experimental |
After completion of study treatment, patients are followed periodically for at least 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| graft versus host disease prophylaxis/therapy | Biological |
| ||
| busulfan |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | 2 years |
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DISEASE CHARACTERISTICS:
Diagnosis of high-risk tumors of the Ewing's family as defined by 1 of the following:
Currently in complete remission (CR) with no evidence of disease (with or without minimal residual disease) or very good partial remission (i.e., CR with an abnormal bone scan) after prior standard or high-dose chemotherapy with local control
HLA-compatible stem cell donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Prockop, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR | MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR |
| FG001 | Related Donors | Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| melphalan | Drug |
|
| thiotepa | Drug |
|
| allogeneic bone marrow transplantation | Procedure |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR | MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR |
| BG001 | Related Donors | Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Overall Objective Response | Posted | Number | participants | 2 years |
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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 | Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR | MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR | 4 | 6 | 6 | 6 | ||
| EG001 | Related Donors | Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant | 0 | 4 | 0 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constitutional Symptoms, other | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Abdomen NOS | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Blood | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Liver dysfunction/failure | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Cholesterol,high(hypercholestremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Gastrointestinal, other | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemorrhage, Urinary NOS | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis (Clin exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| PTT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Trglycrde, high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | General disorders | CTC-3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Prockop | Memorial Sloan Kettering Cancer Center | 212-639-6715 | prockops@mskcc.org |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002066 | Busulfan |
| D008558 | Melphalan |
| D013852 | Thiotepa |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| >=65 years |
|
| Male |
|