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
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
At year 3
No
Ajay Gopal
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
1368.00
NCT00073918
February 1999
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |