AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cediranib; Maleic acid

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