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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT00028795
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed CNS tumor of the following types:
* High grade glioma (HGG) of one of the following histologies:
* Anaplastic astrocytoma (grade III)
* Glioblastoma multiforme (grade IV)
* Gliosarcoma
* Primary spinal cord malignant glioma
* Diffuse intrinsic pontine glioma (DIPG)
* Diagnosed by gadolinium-enhanced MRI
* At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
* No diffuse leptomeningeal disease
* No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:
* Dorsally exophytic brainstem glioma
* Cervico-medullary junction tumor
* Focal low-grade glioma of the midbrain or brainstem
* No diffuse brainstem enlargement due to neurofibromatosis
* No primary brain stem malignant glioma
* No M+ disease (CSF positive for tumor or metastatic disease)
* Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)
PATIENT CHARACTERISTICS:
Age:
* 3 to 21
Performance status:
* Karnofsky 50-100% OR
* Lansky 50-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3\*
* Hemoglobin at least 10.0 g/dL\* NOTE: \*Transfusion independent
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* No other concurrent malignancy
* Concurrent seizure disorder allowed if well controlled on anticonvulsants
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
Biologic:
* No concurrent routine cytokine support
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
Other:
* No prior therapy for HGG or DIPG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00028795
Study Brief:
Protocol Section:
NCT00028795