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
Inclusion 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