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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Expanded Access
The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients
Time frame: Study completion
Safety
Secondary endpoints of the study will be to obtain additional information on the safety of Iodine-131 Anti-B1 Antibody
Time frame: Study completion
efficacy
Secondary endpoints of the study will be to obtain additional information on the efficacy of Iodine-131 Anti-B1 Antibody
Time frame: study completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.