Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Etoposide; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants

• CD20+ large B-cell lymphoma, including those with immunoblastic features

• CD20+ thymic B-cell lymphoma

• No evidence of indolent lymphoma

• No mantle cell lymphomas or equivocal B-cell lymphomas that express markers of mantle cell lymphoma (e.g., cyclin D) or other subtypes

• No known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• CALGB 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm3*

• Platelet count at least 100,000/mm3* NOTE: * Unless due to lymphoma

Hepatic:

• Bilirubin no greater than 2.0 mg/dL* NOTE: * Unless due to lymphoma or Gilbert's disease

Renal:

• Creatinine no greater than 1.5 mg/dL* NOTE: * Unless due to lymphoma

Cardiovascular:

• LVEF greater than 45%

• No ischemic heart disease

• No myocardial infarction or congestive heart failure within the past year

Other:

• HIV negative

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Prior short-course of glucocorticoids allowed

• No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)

• No concurrent steroids except for adrenal failure

• No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

• Prior limited-field radiotherapy allowed

Surgery:

• Not specified