S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. 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, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II, stage III, or stage IV B-cell non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Iodine; Iodine-131 anti-B1 antibody; Liposomal doxorubicin; Prednisone; Rituximab; Tositumomab I-131; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following stage criteria:

• Bulky stage II disease

• Stage III disease

• Stage IV disease

• Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease

• Bidimensionally measurable disease

• Less than 20,000/mcL circulating lymphoid cells on white blood cell (WBC) differential count

• Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available

• Needle aspiration or cytology are not considered adequate

• No clinical evidence of central nervous system (CNS) involvement by lymphoma

• No prior diagnosis of indolent lymphoma

• No histologic transformation

PATIENT CHARACTERISTICS:

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• Ejection fraction ≥ 45% by multiple gated acquisition scan (MUGA) OR

• No significant abnormalities by echocardiogram

Pulmonary

• No requirement for continuous supplemental oxygen

Other

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of the cervix

• No known HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior antibody therapy for lymphoma

Chemotherapy

• No prior chemotherapy for lymphoma

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for lymphoma

Surgery

• No prior solid organ transplantation

Other

• Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol SWOG-8819 (lymphoma tissue repository) is encouraged