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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484874
Recruitment Status : Completed
First Posted : June 11, 2007
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Drug: I-131 Tositumomab therapeutic regimen Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Study Start Date : June 2007
Actual Primary Completion Date : January 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: I-131 Tositumomab therapeutic regimen
Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
Other Name: Brand name: Bexxar

Primary Outcome Measures :
  1. Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma. [ Time Frame: 2 years ]
  2. Overall and Complete Response Rates [ Time Frame: 12 weeks post therapy ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures :
  1. Median Time to Progression Following I-131 Tositumomab Therapy. [ Time Frame: From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented, assessed up to 5 years. ]
  2. Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose [ Time Frame: up to 1 week post-intervention ]
    Percentage of participants with visualized I-131 uptake.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484874

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United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Principal Investigator: Richard L Wahl, MD Johns Hopkins University
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00484874    
Other Study ID Numbers: J0703
NA_00005743 ( Other Identifier: JHM IRB )
First Posted: June 11, 2007    Key Record Dates
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Hodgkin's lymphoma
I-131 Tositumomab
Nuclear Medicine
Monoclonal antibody
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine-131 anti-B1 antibody
Antineoplastic Agents