RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate
cancer cells and deliver radioactive cancer-killing substances to them without harming
normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell
transplantation may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab
with autologous stem cell transplantation in treating older patients who have relapsed or
refractory non-Hodgkin's lymphoma.
- Determine the progression-free survival of older patients with relapsed or refractory
non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous
stem cell transplantation.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity and tolerability of this regimen in these patients.
- Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24
to determine biodistribution. Patients then receive therapeutic iodine I 131
tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until
- Autologous stem cell transplantation: Patients undergo autologous bone marrow or
peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow
transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously
beginning on day 0 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
- Histologically confirmed non-Hodgkin's lymphoma
- CD20+ disease
- Failed at least 1 prior standard systemic therapy
- Persistent lymphoma by physical examination, radiographic studies, bone marrow
evaluations, flow cytometry, or polymerase chain reaction
- Tumor burden less than 500 cc by computed tomography or MRI
- No splenomegaly
- Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved
- No circulating lymphoma cells by morphology or flow cytometry at or near the
time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be
- 10% or less marrow involvement by flow cytometry or morphology if purged bone
marrow is to be used
- No CNS lymphoma
- No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated
- 60 to 80
- SWOG 0-1
- More than 60 days
- See Disease Characteristics
- Bilirubin less than 1.5 mg/dL
- Creatinine less than 2.0 mg/dL
- No active coronary artery disease
- FEV_1 at least 70% of expected
- Vital capacity at least 70% of expected
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- Able to perform self-care during radiation isolation
- No major organ dysfunction
- No major infection
- No circulating anti-mouse antibody
- No other serious medical condition considered to represent contraindications to bone
- No competing causes of death that would predict life span to be less than 10
PRIOR CONCURRENT THERAPY:
- No prior bone marrow or stem cell transplantation
- Not specified
- Not specified
- No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung,
liver, spinal cord, or more than 25% of red marrow)
- Not specified
- More than 30 days since prior systemic antilymphoma therapy