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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00004068
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed brain tumors
* Grade III or IV disease:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic pleomorphic xanthoastrocytoma
* Anaplastic or malignant oligoastrocytoma
* Gemistocytic astrocytoma
* Malignant glioma
* Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement)
* Diffuse pontine gliomas with greater than 2/3 involvement of the pon
PATIENT CHARACTERISTICS:
Age:
* 3 to 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 2,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.0 g/dL
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT less than 5 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior corticosteroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* No more than 28 days since prior definitive surgery for brain tumor
Other:
* Concurrent anticonvulsants allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00004068
Study Brief:
Protocol Section:
NCT00004068