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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00006234
First received: September 11, 2000
Last updated: November 30, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: November 2001
Study Completion Date: March 2006
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006234

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
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 July 26, 2014