Non Hodgkin Lymphoma Clinical Trial
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
Full Description
OBJECTIVES:
Primary
Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
Secondary
Determine disease-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
Stage II, III, or IV disease
Previously untreated disease
Measurable or evaluable disease
No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma
PATIENT CHARACTERISTICS:
Age
61 and over
Performance status
Zubrod 0-2
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count > 1,000/mm^3*
Platelet count > 100,000/mm^3* NOTE: * Unless due to lymphoma-related hypersplenism or bone marrow infiltration
Hepatic
Bilirubin < 2 mg/dL
Hepatitis B surface antigen negative
Hepatitis B core antibody negative
Hepatitis C Virus antibody negative
Renal
Creatinine < 2 mg/dL
Cardiovascular
left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan
No uncontrolled hypertension or cardiac symptoms
Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases:
Diastolic dysfunction
Prior coronary artery bypass graft
Prior percutaneous transluminal coronary angioplasty
Prior stent insertion
Prior radiotherapy to the chest
No myocardial infarction within the past 6 months
No New York Heart Association class II-IV heart failure
No uncontrolled angina
No severe uncontrolled ventricular arrhythmias
No clinically significant pericardial disease
No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)
Other
Not pregnant or nursing
Fertile patients must use effective contraception
No psychiatric illness that would preclude study compliance or giving informed consent
No other major life-threatening illness that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
See Cardiovascular
Surgery
See Cardiovascular
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There are 7 Locations for this study
Fort Smith Arkansas, 72913, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Springfield Missouri, 65804, United States
East Syracuse New York, 13057, United States
Spartanburg South Carolina, 29303, United States
Houston Texas, 77030, United States
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