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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006234
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 1, 2011
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

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 or disease Intervention/treatment Phase
Metastatic Cancer Sarcoma Procedure: peripheral blood stem cell transplantation Radiation: holmium Ho 166 DOTMP Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : March 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 12 and over

Performance status:

  • 0-2

Life expectancy:

  • At least 2 months


  • 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)


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 2.5 times normal


  • Radioisotope glomerular filtration rate, iothalamate clearance, or creatinine clearance at least 60 mL/min


  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


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


  • 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


  • 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


  • See Disease Characteristics
  • No surgical resection of all bone metastases evaluable by PET during and for 1 month after study


  • At least 4 weeks since prior bisphosphonates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006234

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Study Chair: Douglas Hawkins, MD Fred Hutchinson Cancer Research Center

Layout table for additonal information Identifier: NCT00006234     History of Changes
Other Study ID Numbers: 1474.00
CDR0000068159 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011
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:
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Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue