Rituximab, Cyclophosphamide, Vincristine Sulfate, and Prednisone With or Without Liposome-Encapsulated Doxorubicin Citrate in Treating Older Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• 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, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.

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

Details

• Lead Sponsor: Institut Bergonié
• Treatments: Citric Acid; Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell non-Hodgkin lymphoma

• Stage II, III, or IV disease (according to the WHO classification), including all morphological and clinical variants

• No Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy allowed)

• CD20+ disease

• Has ≥ 1 measurable target lesion ≥ 1.1 cm (according to the International Workshop Criteria)

• Poor physiological status, as defined by ≥ 1 of the following criteria:

• WHO performance status 3

• Clinical evaluation and measurement of LVEF that would preclude doxorubicin administration (i.e., LVEF < 50%)

• Creatinine clearance < 50 mL/min

• Serum bilirubin > 30 μmol/L

• Severe comorbidity that would preclude the use of CHOP chemotherapy

• Ineligible for standard R-CHOP therapy

• No cerebral or meningeal involvement

PATIENT CHARACTERISTICS:

• WHO performance status 0-3

• ANC > 750/mm^3

• Platelet count > 50,000/mm^3

• LVEF > 35%

• Able to receive either R-COP or R-COPY therapy

• No congestive heart failure, serious arrhythmia, or myocardial infarction within the past 6 months

• No other malignancy within the past 5 years except for adequately treated basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix

• No active infection

• No active viral hepatitis B or C by serology

• No known HIV positivity

• No hypersensitivity to rituximab, any of its excipients, or to murine proteins

• No documented history of allergy to eggs or egg products

• No psychological, familial, sociological, or geographical condition that would preclude compliance with study treatment or follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior therapy for this cancer

• No prior anthracycline administration with a cumulative dose > 240 mg/m² of doxorubicin hydrochloride or > 400 mg/m² of epirubicin hydrochloride

• More than 30 days since prior participation in another clinical trial involving investigational drugs

• No other concurrent antineoplastic agents