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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00602667
Eligibility Criteria:
Histologically confirmed newly diagnosed CNS tumors of any of the following :
* Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)
* Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
* Pineoblastoma
* Atypical teratoid rhabdoid tumor (ATRT)
* Choroid plexus carcinoma
* High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma,
* Ependymoma (including all ependymoma histological variants)
* Age \< 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and \< 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible.
* Meets criteria for 1 of the following risk groups:
* Low-risk group:
* Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity
* Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist
* No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)
* Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated
* Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible
* Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of \< 1 cm2 confirmed on postoperative CT scan or MRI
* Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \< 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk
* Desmoplastic medulloblastoma patients who are ≥3 -\<5 years of age will NOT be eligible for the low risk arm of the protocol.
* Intermediate-risk group:
* Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis
* Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis
* Medulloblastoma patients who are ≥3 and \< 5 yrs of age irrespective of histology and with no evidence of CNS metastasis
* High-risk group:
* Any eligible histologic diagnosis with evidence of CNS metastasis
* Patients with extraneural metastasis are eligible for treatment on the high-risk group
PATIENT CHARACTERISTICS:
* Lansky performance status ≥ 30 (except for posterior fossa syndrome)
* WBC \> 2,000/mm3
* Platelets \> 50,000/mm3 (without support)
* Hemoglobin \> 8 g/dL (with or without support)
* ANC \> 500/mm3
* Serum creatinine \< 3 times upper limit of normal (ULN)
* ALT \< 5 times ULN
* Total bilirubin \< 3 times ULN
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 31 days since prior definitive surgery
* No prior radiotherapy or chemotherapy other than corticosteroid therapy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT00602667
Study Brief:
Protocol Section:
NCT00602667