Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Iodine-131 anti-B1 antibody; Tositumomab I-131

Criteria

Inclusion Criteria:

• Biopsy-proven Hodgkin's lymphoma that is relapsed or refractory and the patient has previously had a transplant or is ineligible for transplant

• All stages and histologic subtypes of Hodgkin's lymphoma

• Malignant cells may be CD20+ or CD20-

• May have previously had either a non-myeloablative or myeloablative allogeneic or autologous stem cell transplant

• If prior history of greater than 1 transplant, eligible if other entry criteria are met

• No upper limit on the amount of prior chemotherapy

• Must be at least 4 weeks out from their most recent chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU, or mitomycin

• Age 18 or greater

• Karnofsky performance status ≥ 60

• Organ and marrow function within 4 weeks of registration on the protocol as defined below:

• Leukocytes >2,000/mm3

• Absolute neutrophil count >1,000/ mm3

• Platelets >75,000/ mm3

• Hemoglobin >7 g/dL

• Creatinine <2.5 mg/dL

• Less than 25% bone marrow involvement with Hodgkin's lymphoma within 4 weeks of registration on the protocol

• If female, not pregnant or breast feeding

• Ability to understand and the willingness to sign a written informed consent document

• At least one measurable target lesion, measuring 1.5 cm in at least one dimension by standard CT imaging which is FDG -avid on PET/CT.

• 2-year expected survival from other diseases

Exclusion Criteria:

• Receiving any other investigational agents at the same time

• Hypocellular bone marrow (less than or equal to 10% cellularity) or marked decrease in any one (or more) hematopoietic precursor within 4 weeks of registration on the protocol

• Inability to follow basic radiation safety precautions

• Active infections requiring intravenous antibiotics until after resolution of the infection