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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00006234

Collaborator

National Cancer Institute (NCI) (NIH)

Location

51.9

Duration (Months)

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2001

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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