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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006234 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Sarcoma |
Procedure: peripheral blood stem cell transplantation Radiation: holmium Ho 166 DOTMP |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewing's Sarcoma Family of Tumors With Bone Disease |
| Study Start Date: | November 2001 |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Adequate peripheral blood stem cells stored
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
No radiotherapy during and for at least 4 weeks after study
Surgery:
Other:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Douglas Hawkins, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000068159, FHCRC-1474.00, CHMC-S-6007, NCI-G00-1842 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006234 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood rhabdomyosarcoma recurrent adult soft tissue sarcoma adult rhabdomyosarcoma bone metastases |
previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor stage IV adult soft tissue sarcoma |
|
Neoplasms, Muscle Tissue Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Myosarcoma Neoplasms, Nerve Tissue Osteosarcoma Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Neoplastic Processes Neoplasms |
Neoplasms, Bone Tissue Pathologic Processes Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Sarcoma Neoplasms, Connective Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Rhabdomyosarcoma |