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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT00085202
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Medulloblastoma
* Supratentorial primitive neuroectodermal tumor (PNET)
* PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma)
* Atypical teratoid rhabdoid tumor (ATRT)
* Definitive surgery for CNS tumor within the past 31 days
* Meets one of the following risk criteria:
* Average-risk disease
* Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
* T4 disease eligible if all of the following are true:
* Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
* Residual tumor or imaging abnormality whose size is \< 1.5 cm\^2
* No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery
* Brain stem invasion allowed in the absence of residual tumor (tumor \< 1.5 cm\^2 by imaging)
* High-risk disease meeting one of the following criteria:
* Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF)
* Presence of residual disease \> 1.5 cm\^2 at the primary site after surgery
PATIENT CHARACTERISTICS:
Age
* 3 to 21 at diagnosis
Performance status
* Lansky 30-100% (\< 10 years old)
* Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome)
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin \> 8 g/dL
* WBC \> 2,000/mm\^3
* Absolute neutrophil count \> 500/mm\^3
* Platelet count \> 50,000/mm\^3
Hepatic
* ALT \< 5 times normal
* Bilirubin \< 3.0 mg/dL
Renal
* Creatinine \< 2.0 mg/dL OR
* Creatinine clearance \> 70 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Prior corticosteroid therapy allowed
Radiotherapy
* No prior radiotherapy
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00085202
Study Brief:
Protocol Section:
NCT00085202