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| ID | Type | Description | Link |
|---|---|---|---|
| FHCRC-1474.00 | |||
| CHMC-S-6007 | |||
| NCI-G00-1842 | |||
| CDR0000068159 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Radioactive drugs, such as holmium Ho 166 DOTMP, may carry radiation directly to cancer cells and not harm normal cells. Peripheral stem cell transplantation may be able to replace stem cells that were destroyed by the radioactive drug.
PURPOSE: This Phase I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewing's sarcoma or rhabdomyosarcoma that has spread to the bone.
OBJECTIVES:
OUTLINE: Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7 and an assigned dose over 10 minutes on day 0. Autologous peripheral blood stem cells are infused on days 7-10.
Patients are followed at least weekly for 4 weeks and then monthly for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 4 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral blood stem cell transplantation | Procedure | |||
| holmium Ho 166 DOTMP | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases
Soft tissue, pulmonary, and/or bone marrow metastases in addition to cortical bone allowed
No patients under 10 years old with embryonal rhabdomyosarcoma
Adequate peripheral blood stem cells stored
No impending bone fracture or spinal cord compression
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
See Disease Characteristics
See Biologic therapy
Recovered from prior radiotherapy
No prior maximum tolerable radiotherapy (greater than 30 Gy) to the spinal cord
No prior therapeutic doses of bone-seeking radiopharmaceutical (e.g., samarium Sa 153 lexidronam pentasodium EDTMP)
No radiotherapy during and for at least 4 weeks after study
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Hawkins, MD | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D012509 | Sarcoma |
| D012208 | Rhabdomyosarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| 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 |
|---|---|
| D036102 | Peripheral Blood Stem Cell Transplantation |
| C093387 | holmium-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetrakis(methylenephosphonic acid) |
| ID | Term |
|---|---|
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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