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

NCT ID: NCT00484874

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2015-11-30

Brief 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.

Detailed 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.

Conditions

Hodgkin's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A Single Dose of I-131 Tositumomab

I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.

Group Type: EXPERIMENTAL

I-131 Tositumomab therapeutic regimen

Intervention Type: DRUG

Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.

Interventions

I-131 Tositumomab therapeutic regimen

Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.

Intervention Type: DRUG

Other Intervention Names

Brand name: Bexxar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L Wahl, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00005743

Identifier Type: OTHER

Identifier Source: secondary_id

J0703

Identifier Type: -

Identifier Source: org_study_id