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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00030667
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed solid tumors including the following:
* Ewing's sarcoma
* Bone or soft tissue primitive neuroectodermal tumor
* Osteosarcoma
* Neuroblastoma
* Desmoplastic small round cell tumor
* Synovial cell sarcoma
* Gastrointestinal stromal tumor (GIST)
* Metastatic pulmonary disease eligible
* No pleural effusion of any size or definite radiologic evidence of pleural-based disease
* Recurrent or refractory to conventional therapy
* GIST eligible at initial presentation
* Tumor tissue blocks must be available
* At least 1 measurable lesion
* At least 20 mm by conventional techniques
* At least 10 mm by spiral CT scan
* Lesions assessable only by radionuclide scan are not considered measurable
* Performance status - Lansky 50-100% (≤ 10 years of age)
* Performance status - Karnofsky 50-100% (\> 10 years of age)
* At least 2 months
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 75,000/mm\^3\* (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL\* (RBC transfusions allowed)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* INR \< 1.5
* PTT ≤ ULN
* Fibrinogen ≥ lower limit of normal
* Creatinine normal for age
* Glomerular filtration rate ≥ 70 mL/min
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* At least 1 week since prior biologic therapy or immunotherapy and recovered
* At least 1 week since prior growth factors
* No concurrent immunomodulating agents
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No concurrent chemotherapy
* No concurrent steroids
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis
* At least 6 weeks since other prior substantial bone marrow radiation
* No concurrent radiotherapy during first course of treatment
* Concurrent palliative radiotherapy to local painful lesions allowed after first course of treatment provided there is no evidence of disease progression and at least 1 measurable lesion remains outside radiation port
* No concurrent therapeutic doses of warfarin
* No concurrent anticonvulsants that induce the cytochrome p450 enzyme system (e.g., phenytoin, carbamazepine, and phenobarbital)
* Concurrent benzodiazepines and gabapentin allowed
* Concurrent low-molecular weight heparin allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT00030667
Study Brief:
Protocol Section:
NCT00030667