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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT00613132
Eligibility Criteria:
Inclusion Criteria:
* Pts w confirmed GBM, GS, AA, AO \& AOA are presenting in 1st, 2nd/3rd recurrence/relapse
* Pts without tumor biopsy \<1 wk/surgical resection \<2 wks prior to starting study drug
* For stratum of non-EIAED pts, each pts off all enzyme inducing anticonvulsants for \>2 wks prior to starting study drug
* Pts should be on non-increasing dose of steroids for \>7 days prior to obtaining baseline Gd-MRI of brain
* Pts should be on non-increasing dose of steroids for \>7 days prior to starting study drug
* Pts w previous implantation of Gliadel may be eligible after discussion between investigator \& sponsor
* Multifocal disease is eligible
* Age \>18 yrs
* KPS \>70
* Hematology: ANC\>1.5 x 10\^9/L, Hgb\>9 g/dL, Platelets\>100 x 10\^9/L
* Biochemistry: K≥ LLN/correctable w supplement, Total Ca≥ LLN/correctable w supplement, Mg≥ LLN/correctable w supplement, P≥ LLN/correctable w supplement, AST/SGOT \& ALT/SGPT \<2.5 x ULN, Serum bilirubin \<1.5 x ULN, Serum creatinine \<1.5 x ULN/measured 24hr CrCl\<0 mL/min/1.73m2, \& Cholesterol≤ 00 mg/dL \& triglyceride≤2.5 ULN
* Life expectancy ≥12wks
* Written informed consent obtained prior to any screening procedures
Exclusion Criteria:
* Pts w any peripheral neuropathy ≥CTCAE gr2
* Pts w unresolved diarrhea ≥CTCAE gr2
* History of impaired cardiac function
* Obligate use of cardiac pacemaker, Congenital long QT syndrome, History or presence of ventricular or atrial tachyarrhythmias, Clinically significant resting bradycardia , Right bundle branch block + left anterior hemiblock
* Other clinically significant cardiac diseases
* Uncontrolled Db
* Active or uncontrolled infection requiring intravenous antibiotics
* Impairment of GI function/GI disease that may significantly alter absorption of Gleevec, hydroxyurea and/or RAD001
* Acute/chronic liver/renal disease
* Other concurrent severe and/or uncontrolled medical condition that could cause unacceptable safety risks/compromise compliance w protocol
* Treatment w any hematopoietic colony-stimulating factor ≤2wks prior to starting study drug. Erythropoietin is allowed
* Pts w history of CHF/arrhythmias who are receiving treatment w digoxin/verapamil, \& treatment cannot be discontinued/switched to different drug prior to starting study drug
* Pts taking warfarin sodium
* Pts received treatment w PDGF/mTOR directed therapies
* Pts received chemo ≤ 4wks prior to starting study drug/have not recovered from side effects of such therapy
* Pts received immunotherapy ≤2 wks prior to starting study drug/have not recovered from side effects of such therapy
* Pts received investigational drugs ≤4 wks prior to starting study drug/have not recovered from side effects of such therapy
* Pts received XRT ≤4 wks prior to starting study drug/have not recovered from side effects of such therapy
* Pts undergone major non-CNS surgery ≤2 wks prior to starting study drug/pts have not recovered from side effects of such therapy
* Cardiac pacemaker, Ferromagnetic metal implants other than those approved as safe for use in MR scanners, Claustrophobia, Obesity
* Female pts are pregnant/breast feeding,/adults of reproductive potential not employing effective method of birth control. Barrier contraceptives must be used throughout trial in both sexes. Oral, implantable/injectable contraceptives may be affected by cytochrome P450 interactions, \& are therefore not considered effective for study. Women of childbearing potential have negative serum pregnancy test 48hrs prior to administration of Gleevec, hydroxyurea and/or RAD001.
* Known diagnosis of HIV infection
* Pts w history of another primary malignancy that is currently clinically significant/currently requires active intervention
* Pts unwilling to/unable to comply w protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00613132
Study Brief:
Protocol Section:
NCT00613132