Non Hodgkin Lymphoma Clinical Trial
Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
Summary
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.
Full Description
OBJECTIVES:
Primary
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.
Secondary
Determine the overall survival of patients treated with this regimen.
Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE:
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 day -4.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
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 used
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 lymphocytic lymphoma
PATIENT CHARACTERISTICS:
Age
60 to 80
Performance status
SWOG 0-1
Life expectancy
More than 60 days
Hematopoietic
See Disease Characteristics
Hepatic
Bilirubin less than 1.5 mg/dL
Renal
Creatinine less than 2.0 mg/dL
Cardiovascular
No active coronary artery disease
Pulmonary
FEV_1 at least 70% of expected
Vital capacity at least 70% of expected
Other
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 marrow transplantation
No competing causes of death that would predict life span to be less than 10 additional years
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior bone marrow or stem cell transplantation
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
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)
Surgery
Not specified
Other
More than 30 days since prior systemic antilymphoma therapy
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There is 1 Location for this study
Seattle Washington, 98109, United States
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