AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
Criteria: AST/ALT =< 2.5 times upper limit of normal Creatinine normal OR creatinine clearance >= 60 mL/min Measurable contrast-enhancing tumor >= 1 cm in longest diameter by baseline MRI or CT scan: Patient must have been on no steroids OR a stable dose of steroids for >= 5 days prior to baseline MRI or CT scan Patients who are on steroids must be maintained on a stable corticosteroid regimen from baseline scan until the start of study treatment No intratumoral or peritumoral hemorrhage by MRI Karnofsky performance status >= 60% No other concurrent malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast Mini-mental status examination score >= 15 Histologically confirmed glioblastoma multiforme Platelet count >= 100,000/mm3 Hemoglobin >= 8 g/dL Bilirubin normal No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 Mean QTc =< 470 msec (with Bazett's correction) on screening electrocardiogram No history of familial long QT syndrome No greater than +1 proteinuria on 2 consecutive dipsticks taken >= 1 week apart unless first urinalysis shows no protein No uncontrolled intercurrent illness, including, but not limited to, any of the following: Hypertension; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Psychiatric illness/social situations that would limit compliance with study requirements No known coagulopathy that increases the risk of bleeding No history of clinically significant hemorrhages Recovered from toxicity of prior therapy At least 3 months since prior radiation therapy, including cranial radiation therapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) At least 3 weeks since prior molecularly-targeted agents At least 4 weeks since prior major surgery No more than 2 prior chemotherapy regimens or antineoplastic drugs More than 30 days since prior participation in an investigational trial At least 2 weeks since prior enzyme-inducing antiepileptic drugs (EIAEDs) No concurrent EIAEDs; Concurrent non-EIAEDs allowed No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No concurrent vascular endothelial growth factor inhibitors: Prior thalidomide or lenolidomide allowed No concurrent anticoagulants (e.g., warfarin) or antiplatelet agents including aspirin No other concurrent anticancer agents or therapies No concurrent grapefruit juice WBC >= 3,000/mm3 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Absolute neutrophil count >= 1,500/mm3
Sites / Locations
- Massachusetts General Hospital Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive oral AZD2171 once daily on days 1-28.