Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Ortho Biotech, Inc.
• Treatments: Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

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