Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma|
- Expanded Access [ Time Frame: Study completion ] [ Designated as safety issue: No ]The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients
- Safety [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]Secondary endpoints of the study will be to obtain additional information on the safety of Iodine-131 Anti-B1 Antibody
- efficacy [ Time Frame: study completion ] [ Designated as safety issue: No ]Secondary endpoints of the study will be to obtain additional information on the efficacy of Iodine-131 Anti-B1 Antibody
|Study Start Date:||November 1998|
|Study Completion Date:||November 2012|
|Primary Completion Date:||April 2002 (Final data collection date for primary outcome measure)|
Radiation: tositumomab and iodine I 131 tositumomab
OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma.
OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: Expanded Access Trial, no maximum accrual
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004874
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-3330|
|Study Chair:||Julie M. Vose, MD||University of Nebraska|