Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Tositumomab and/or Iodine I 131 Tositumomab, B-cell non-Hodgkin's lymphoma, Dose-limiting toxicity, Bexxar
Eligibility Criteria
Inclusion Criteria
- Subjects had histologically-confirmed NHL.
- Subjects with low-, intermediate-, or high-grade histologies, according to the International Working Formulation.
- Subjects had relapsed after or had failed to respond to at least 1 prior chemotherapy regimen.
- Subjects had evidence that their tumor tissue expressed the CD20 antigen.
Exclusion Criteria
- ≥25% bone marrow involvement.
- Absolute granulocyte count ≥1500 cells/mm3 or platelet count ≤100,000 platelets/mm3.
- Creatinine ≥2.0 mg/dL, bilirubin ≥2.0 mg/dL.
- Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks of study entry.
- Active infection, collagen vascular disease, vasculitis, glomerulonephritis, New York Heart Association class II or IV heart disease and/or serious illness.
- Prior external beam radiation therapy such that the maximum tolerated dose level for any normal organ would be exceeded by additional irradiation.
- Pregnancy.
- Allergy to iodine or previous sensitization to mouse protein as documented by positive anti-mouse antibody ELISA test.
- Known brain metastases.
Sites / Locations
Arms of the Study
Arm 1
Experimental
open-label, dose escalation
Each subject will undergo two phases of study. The first phase, termed "tracer Study", involves the injection of low-radioactivity doses (about 5 mCi) of 131-I anti-B1 for the purposes of determining the rate of whole body clearance of radiation so that a whole body radiation can be calculated. The calculated whole-body radiation dose per mCi administered can then be used to determined how many mCi will be required to deliver a specified whole-body radiation dose in the second phase of the study for each patient, termed radio-immunotherapy dose in a tracer-projected whole-body radiation dose will be used for dose escalation with a minimum of three subjects per dose level.