Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | March 2006 |
OBJECTIVES:
- Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases.
- Provide treatment with holmium Ho 166 DOTMP for these patients.
- Determine the toxicity and pharmacokinetics of this drug in these patients.
- Determine the change in tumor cell content in peripheral blood and bone marrow after treatment with this drug in these patients.
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
- Refractory to conventional therapy OR
- Responsive to conventional therapy with osseous metastases at diagnosis that are extensive enough to preclude concurrent radiotherapy to all sites
Soft tissue, pulmonary, and/or bone marrow metastases in addition to cortical bone allowed
- Extraosseous sites of disease allowed if amenable to surgical resection or external beam radiotherapy
- No patients under 10 years old with embryonal rhabdomyosarcoma
Adequate peripheral blood stem cells stored
- At least 2,500,000 CD34+ cells/kg
- No impending bone fracture or spinal cord compression
PATIENT CHARACTERISTICS:
Age:
- 12 and over
Performance status:
- 0-2
Life expectancy:
- At least 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (RBC transfusion allowed)
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 2.5 times normal
Renal:
- Radioisotope glomerular filtration rate, iothalamate clearance, or creatinine clearance at least 60 mL/min
Other:
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
- At least 3 months since prior bone marrow or peripheral blood stem cell transplantation (6 months for total body irradiation conditioning) and recovered
- At least 1 week since prior cytokines
- No immunomodulators during and for at least 4 weeks after study
- No concurrent cytokines
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No more than 3 prior systemic chemotherapy regimens
- No systemic chemotherapy during and for at least 4 weeks after study
Endocrine therapy:
- Not specified
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
- Local radiotherapy to any tumor site allowed provided at least 1 evaluable lesion is untreated
Surgery:
- See Disease Characteristics
- No surgical resection of all bone metastases evaluable by PET during and for 1 month after study
Other:
- At least 4 weeks since prior bisphosphonates
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006234 History of Changes |
| Other Study ID Numbers: | 1474.00, FHCRC-1474.00, CHMC-S-6007, NCI-G00-1842, CDR0000068159 |
| Study First Received: | September 11, 2000 |
| Last Updated: | November 30, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Rhabdomyosarcoma Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplastic Processes Pathologic Processes Myosarcoma Neoplasms, Muscle Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013