Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2019-03-01
• 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 patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Liposomal doxorubicin; Podophyllotoxin; Prednisone; Rituximab; Vincristine

Criteria

INCLUSION CRITERIA:

• Diffuse large B-cell non-Hodgkin's lymphoma

• Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease

• The following lymphoma types are excluded:

• Primary central nervous system lymphoma

• Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections)

• Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated)

• Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant)

• Measurable disease

• Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters)

• Measurable disease in the liver is required if the liver is the only site of lymphoma involvement

• Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

• For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count > 100,000/mm^3

• Creatinine < 2.0 mg/dL

• Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

EXCLUSION CRITERIA:

• Prior chemotherapy or radiation therapy for lymphoma

• Prior anthracyclines or platinum compounds used as systemic chemotherapy

• Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

• Concurrent pentostatin or trastuzumab (Herceptin®)

• Pregnant or nursing

• Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free

• HIV positive