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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. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplantation may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with etoposide and cyclophosphamide followed by autologous stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
- Determine the progression-free survival of patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab, etoposide, and cyclophosphamide followed by autologous stem cell transplantation.
- Determine the safety of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to REAL classification histology (mantle cell lymphoma vs indolent lymphoma vs aggressive lymphoma).
- 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 approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
- Chemotherapy: Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV on day -2.
- 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 140 patients (40 with mantle cell lymphoma, 50 with indolent lymphoma, and 50 with aggressive lymphoma) will be accrued for this study within 4.6-9.2 years.
Masking: Open Label, Primary Purpose: Treatment
filgrastim, sargramostim, cyclophosphamide, etoposide, autologous bone marrow transplantation, peripheral blood stem cell transplantation, tositumomab and iodine I 131 tositumomab
Seattle Cancer Care Alliance
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:45-0400
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow do...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation m...
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow docto...
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