Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00484874|
Recruitment Status : Completed
First Posted : June 11, 2007
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Disease||Drug: I-131 Tositumomab therapeutic regimen||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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.
- 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. ]
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00484874
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Richard L Wahl, MD||Johns Hopkins University|