Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00006234
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00006234
Study Brief:
Protocol Section:
NCT00006234