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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT00124657
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of high-grade glioma of 1 of the following types:
* Unfavorable low-grade glioma
* Gliomatosis cerebri or bithalamic involvement
* Histologically confirmed high-grade glioma (WHO grade III or IV) of 1 of the following subtypes:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic oligoastrocytoma
* Anaplastic ganglioglioma
* Pleomorphic xanthoastrocytoma with anaplastic features
* Malignant glioneuronal tumor
* Glioblastoma multiforme
* Gliosarcoma
* Newly diagnosed disease
* Intracranial or spinal cord tumors allowed
PATIENT CHARACTERISTICS:
Age
* 3 to 21
Performance status
* Karnofsky 40-100% (age 17 to 21 years) OR
* Lansky 40-100% (age 3 to 16 years)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* SGPT \< 5 times ULN
* Albumin ≥ 2 g/dL
Renal
* Creatinine \< 2 times normal OR
* Glomerular filtration rate \> 70 mL/min
Cardiovascular
* No significant cardiovascular problem
Pulmonary
* No significant pulmonary problem
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled infection
* No significant medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior or concurrent biologic agents
Chemotherapy
* No prior or concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* No more than 42 days since prior surgery
Other
* No other prior or concurrent anticancer or experimental treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00124657
Study Brief:
Protocol Section:
NCT00124657