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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00053118
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary central nervous system malignancy
* Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen
PATIENT CHARACTERISTICS:
Age
* 18 and under at initial diagnosis
Performance status
* ECOG 0-2
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count greater than 750/mm\^3
* WBC greater than 2,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect
Hepatic
* Liver function tests less than 2 times normal OR
* Absence of active hepatitis by liver biopsy
* Bilirubin less than 1.5 mg/dL
Renal
* Glomerular filtration rate greater than 60 mL/min by radionucleotide assay
Cardiovascular
* Ejection fraction at least 45%
Pulmonary
* Clinically normal pulmonary function (patients 5 years of age and under)
* FEV\_1 and FVC at least 50% (patients over 5 years of age) OR
* Arterial blood gas normal and DLCO greater than 50%
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No mucositis or mucosal infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 3 weeks since prior systemic cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 6 months since prior radiotherapy to the pelvis or spine
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00053118
Study Brief:
Protocol Section:
NCT00053118