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

Completed · Phase 1/Phase 2

Conditions studied: Hodgkin's Disease

In brief

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.

Key facts

Study ID

NCT00484874

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

12

Starts

2007-06-01

Expected to finish

2015-11-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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