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

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hodgkin's Disease

Treatments

Drug: I-131 Tositumomab therapeutic regimen

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00484874

J0703

NA_00005743 (Other Identifier)

Details and patient eligibility

About

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.

Full description

One third of patients with Hodgkin's lymphoma (HL) do not respond to or have their disease come back after their first therapy. These patients often then receive high-dose chemotherapy and blood or marrow transplant. Despite high response rates after transplant, a significant number, 26-65%, of these patients have their disease come back again. After transplant, therapy options are limited and alternative therapies for patients with HL who have relapsed post-transplant or who are ineligible for transplant are needed. Based on recent studies about how HL develops and good results of patient studies evaluating the use of the unlabeled anti-CD20 antibody Rituximab in HL, we think that radioimmunotherapy (RIT) with I-131 Tositumomab(Bexxar®) will be an effective alternative therapy in patients with relapsed/refractory HL who are post or ineligible for transplant.

The rationale for the use of RIT in cancer is that radiolabeled monoclonal antibodies will specifically target and irradiate tumor cells but not normal tissues. The specific tumor targeting of RIT theoretically allows higher doses of radiation to be delivered to tumor as compared to external beam radiation because the effects of the radiation on normal tissues is less with RIT. Iodine-131 Tositumomab (Bexxar®) was approved by the FDA for another type of lymphoma in 2003. The antibody (Tositumomab) recognizes and attaches to a protein on lymphoma cells and can kill these cells. The radioisotope (I-131) can help the antibody kill cells better.

Iodine-131 Tositumomab (Bexxar®) is given through a vein in the arm. Iodine-131 Tositumomab (Bexxar®) is given in an outpatient setting.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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