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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT00526812
Eligibility Criteria:
Inclusion Criteria:
* Prior histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme, or gliosarcoma, for whom no other effective therapy is available.
* A prior histologic diagnosis of a lower grade of glioma is allowed if there is current histologic proof of progression to a diagnosis of AA, AO, AOA, GBM or GS
* Unequivocal evidence of recurrence or progression by neuroimaging procedure.
* Surgical resection at least 2 weeks prior to enrollment and must have completely recovered from the side effects.
* A stable dose of steroids for at least 7 days prior to obtaining the Gd-MRI of the brain.
* Previously implanted Gliadel® wafer may be eligible.
* Karnofsky Performance Status (KPS) of ≥ 60.
* Laboratory parameters: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dl, Platelets ≥ 100 x 109/L, AST and ALT ≤ 3.0 x Upper Limit of Normal (ULN), Serum bilirubin ≤ 1.5 x ULN, Serum creatinine ≤ 1.5 x ULN and 24 hour creatinine clearance ≥ 50 ml/min
* Life expectancy of greater than 12 weeks.
* Written informed consent obtained.
Exclusion Criteria:
* Pregnancy or breast feeding, or adults of reproductive potential not employing an effective method of birth control
* Total urinary protein in 24 hours urine collection \> 500 mg
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study.
* Impaired cardiac function, other significant prior cardiac disease or arrhythmia of any
* A history of CHF or arrhythmias.
* Therapeutic doses of warfarin sodium (Coumadin®).
* Prior or concurrent therapy, or not recovered from the toxic effects of such therapy: investigational drugs, chemotherapy, metronomic daily dosing of chemotherapy agents, biologic, immunotherapy or cytostatic agents within 4 weeks prior to study entry; radiation therapy within 2 weeks prior to study entry, any medication known to cause QT interval prolongation
* Any surgery other than resection of a brain tumor within 2 weeks prior to enrollment.
* A contraindication to MRI imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00526812
Study Brief:
Protocol Section:
NCT00526812