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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
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

June 8, 2007
June 11, 2007
October 14, 2016
August 1, 2018
August 1, 2018
June 2007
January 2014   (Final data collection date for primary outcome measure)
  • 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.
  • Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma who are post or ineligible for transplant [ Time Frame: 2 years ]
  • Overall and Complete Response Rates [ Time Frame: 12 weeks post therapy ]
Complete list of historical versions of study NCT00484874 on ClinicalTrials.gov Archive Site
  • 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.
  • Duration of response of Hodgkin's lymphoma to I-131 Tositumomab [ Time Frame: From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented ]
  • Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose [ Time Frame: Within one week of receiving dosimetric dose of I-131 Tositumomab ]
Not Provided
Not Provided
 
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
A Phase I/II Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin's Disease
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
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.
Intervention: Drug: I-131 Tositumomab therapeutic regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
30
November 2015
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00484874
J0703
NA_00005743 ( Other Identifier: JHM IRB )
Yes
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
Not Provided
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
GlaxoSmithKline
Principal Investigator: Richard L Wahl, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP