AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Histological confirmation of B-cell chronic lymphocytic leukemia (B-CLL) Peripheral blood lymphocyte count > 5,000/mm³ Small to moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes Bone marrow aspirate with ≥ 30% lymphoid cells Monoclonality of B lymphocytes by immunophenotyping, demonstrating all of the following: B-cell markers with CD5 antigen in the absence of other pan-T-cell markers (CD3, CD2, etc.) CD19 and/or CD20 Expression of CD23 on the CLL cells OR dim B-cell expression of kappa or lambda light chains Disease must be refractory to or progressive after treatment with at least 1 course containing a purine nucleoside analog (e.g., fludarabine, cladribine, or pentostatin) Life expectancy > 6 months ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 50,000/mm³ Hemoglobin ≥ 8 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) Patients with Gilbert's syndrome may have a bilirubin ≥ 1.5 times ULN AST and ALT ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergies to compounds similar to AZD2171 QTc prolongation < 500 msec No other significant ECG abnormality No history of familial long QT syndrome Proteinuria < 1+ by dipstick OR protein < 1 g/24 hr urine collection No known HIV positivity No New York Heart Association (NYHA) class III or IV disease NYHA class II disease controlled with treatment and monitoring allowed No other uncontrolled illness including, but not limited to, the following: Hypertension Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situations that would limit compliance See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, anti-vascular endothelial growth factor (VEGF) treatment, or major surgery and recovered More than 30 days since prior investigational agents No concurrent drugs or biologics with proarrhythmic potential No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.