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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00003203
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven high-risk CNS embryonal tumors, including:
* Primitive neuroectodermal tumors
* Atypical teratoid/rhabdoid tumor
* Medulloblastoma
* Desmoplastic medulloblastoma
* Ependymoblastoma
* Medullomyoblastoma
* Spongioblastoma
* Spongioblastoma polare
* Primitive polar spongioblastoma
* Neuroepitheliomatous neoplasms
* Medulloepithelioma
* Neuroblastoma
* Pineoblastoma
* No bone marrow involvement or bone metastases
* No M4 disease
* M3 disease must have evidence of tumor on spinal MRI
PATIENT CHARACTERISTICS:
Age:
* 3 to 21 at diagnosis
Performance status:
* Not specified
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3 (transfusion independent)
* Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed)
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGOT/SGPT less than 2.5 times normal
Renal:
* Creatinine less than 1.5 times upper limit of normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* Prior definitive surgery allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00003203
Study Brief:
Protocol Section:
NCT00003203