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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT00268359
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
* Glioblastoma multiforme
* Gliosarcoma
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy
* Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan
* Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Hematocrit \> 29%
* Absolute neutrophil count \> 1,500/mm\^3
* Platelets \> 125,000/mm\^3
* Serum SGOT and bilirubin \< 1.5 times upper limit of normal
* Creatinine \< 1.5 mg/dL
* Urine protein:creatinine ratio ≤ 1.0
* Blood pressure ≤ 150/100 mmHg
* No unstable angina
* No New York Heart Association class II or greater congestive heart failure
* No myocardial infarction within the past 6 months
* No stroke within the past 6 months
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
* At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
* At least 6 weeks since prior surgical resection
* No previous major surgical procedures or open biopsies within 28 days prior to study entry
* No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
* No anticipated need for major surgical procedures during the course of the study
* No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00268359
Study Brief:
Protocol Section:
NCT00268359