Status:
COMPLETED
AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 som...
Detailed Description
OBJECTIVES: I. Evaluate the response rate in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) treated with AZD2171. II. Evaluate the toxicity of AZD2171 in patients w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00321724
Start Date
May 1 2006
Last Update
January 15 2013
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905