Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma
This phase II trial is studying how well giving iodine I 131 tositumomab together with etoposide and cyclophosphamide followed by autologous stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplant may kill more cancer cells
PRIMARY OBJECTIVES:
I. To assess the progression-free survival of patients receiving 131 I labeled tositumomab
antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous
transplantation.
II. To examine the potential efficacy of 131 I labeled tositumomab antibody, etoposide
(VP-16) and cyclophosphamide (CY) followed by autologous transplantation.
SECONDARY OBJECTIVES:
I. To assess the overall survival of patients receiving 131 I labeled tositumomab antibody,
etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.
II. To evaluate the toxicity and tolerability of the above therapy.
OUTLINE:
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab intravenously
(IV) 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 on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell
transplant on day 0.
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and
then annually thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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