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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00100802
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:
* Anaplastic astrocytoma
* Glioblastoma multiforme
* Gliosarcoma
* Primary spinal cord malignant gliomas allowed
* No primary brainstem tumors
* Has undergone surgical resection or biopsy of the tumor within the past 31 days
* Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries
* Post-operative MRI not required for patients who undergo biopsy only
* No evidence of neuraxis dissemination
* Spine MRI and cerebrospinal fluid cytology required only if clinically indicated
* Performance status - Karnofsky 50-100% (for patients \> 16 years of age)
* Performance status - Lansky 50-100% (for patients ≤ 16 years of age)
* At least 8 weeks
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8 g/dL (transfusions allowed)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* Albumin ≥ 2 g/dL
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry ≥ 94% (if determination is clinically indicated)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study participation
* Able to swallow oral medication
* Seizures allowed provided they are well controlled with anticonvulsants
* No hypersensitivity to temozolomide
* No prior biologic agents
* No prior chemotherapy
* Prior corticosteroids allowed
* No concurrent corticosteroids as an antiemetic
* Concurrent corticosteroids allowed only for treatment of increased intracranial pressure
* No concurrent radiotherapy using cobalt-60
* See Disease Characteristics
* No other prior treatment
* No concurrent phenobarbital or cimetidine
* No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00100802
Study Brief:
Protocol Section:
NCT00100802