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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00387933
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma
* Grade 3 or 4 disease
* In first, second, or third recurrence or relapse
* Multifocal disease allowed
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count \> 1,500/mm\^3
* Hemoglobin \> 9 g/dL
* Platelet count \> 100,000/mm\^3
* Potassium normal\*
* Total calcium (corrected) normal\*
* Magnesium normal\*
* Phosphorus normal\*
* aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Negative proteinuria by dipstick OR total urinary protein ≤ 500 mg with creatinine clearance ≥ 50 mL/min by 24-hour urine collection
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No acute or chronic liver or renal disease
* left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram
* No complete left bundle branch block
* No obligate use of a cardiac pacemaker
* No congenital long QT syndrome
* No history of or current ventricular or atrial tachyarrhythmias
* No clinically significant resting bradycardia (i.e., heart rate \< 50 beats/minute)
* No right bundle branch block with left anterior hemiblock (bifascicular block)
* No uncontrolled hypertension ≥ grade 2, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
* No concurrent unstable angina pectoris or angina pectoris within the past 3 months
* No congestive heart failure (CHF)
* No history of CHF or arrhythmias requiring concurrent digoxin or verapamil
* No acute myocardial infarction within the past 3 months
* No other impaired cardiac function or clinically significant cardiac disease
* No peripheral neuropathy ≥ grade 2
* No unresolved diarrhea ≥ grade 2
* No uncontrolled diabetes
* No active or uncontrolled infection requiring intravenous antibiotics
* No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib, hydroxyurea, and/or everolimus, including any of the following:
* Ulcerative disease
* Uncontrolled nausea, vomiting, or diarrhea
* Malabsorption syndrome
* Small bowel resection
* No other concurrent severe and/or uncontrolled medical condition that would preclude study participation or compliance
* No known HIV positivity
* No other primary malignancy that is clinically significant or requires active intervention NOTE: \*Supplement allowed
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior tumor biopsy (4 weeks since prior surgical resection)
* Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed at discretion of principal investigator
* Prior hydroxyurea allowed
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 1 week for metronomic-dosed chemotherapy \[e.g., daily etoposide hydrochloride or cyclophosphamide\]) and recovered
* More than 4 weeks since prior radiotherapy and recovered
* More than 2 weeks since prior immunotherapy and recovered
* More than 4 weeks since prior investigational drugs and recovered
* No prior platelet-derived growth factor- or vascular endothelial growth factor-directed therapies
* More than 2 weeks since prior hematopoietic colony-stimulating factor (e.g., filgrastim \[G-CSF\] or sargramostim \[Granulocyte-macrophage colony-stimulating factor (GM-CSF)\])
* Prior epoetin alfa allowed
* No concurrent warfarin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00387933
Study Brief:
Protocol Section:
NCT00387933