Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Status: | Archived |
---|---|
Conditions: | Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
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
RATIONALE: 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 transplantation may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together
with etoposide and cyclophosphamide followed by autologous stem cell transplantation works
in treating patients with relapsed or refractory non-Hodgkin's lymphoma
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 in patients with
relapsed or refractory non-Hodgkin's lymphoma.
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 131 I labeled tositumomab antibody,
etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation.
OUTLINE:
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab 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 intravenously (IV) on day -4 and cyclophosphamide
IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell
transplantation on day 0.
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and
then annually thereafter.
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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