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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00484874
First received: June 8, 2007
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Hodgkin's Disease
Drug: I-131 Tositumomab therapeutic regimen
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Overall and complete response rates [ Time Frame: 12 weeks post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484874

Contacts
Contact: Heather A Jacene, MD 617-632-3767 hjacene1@jhmi.edu
Contact: John Crandall 410-502-2186 jcranda1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Contact: Heather A Jacene, MD    410-617-3767    hjacene1@jhmi.edu   
Contact: John Crandall    410-502-2186    jcranda1@jhmi.edu   
Sub-Investigator: Heather A Jacene, MD         
Principal Investigator: Richard L Wahl, MD         
Sub-Investigator: Richard Ambinder, MD, PhD         
Sub-Investigator: Yvette Kasamon, MD         
Sub-Investigator: George Sgouros, PhD         
Sub-Investigator: Eric Frey, PhD         
Sub-Investigator: Wayne Kasecamp, CNMT         
Sub-Investigator: Donna Serena, RN         
Sub-Investigator: Steven Piantadosi, MD, PhD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
GlaxoSmithKline
Investigators
Principal Investigator: Richard L Wahl, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Heather Jacene, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00484874     History of Changes
Other Study ID Numbers: J0703, NA00005743
Study First Received: June 8, 2007
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Hodgkin's lymphoma
Radioimmunotherapy
Bexxar
I-131 Tositumomab
Safety
Efficacy
Nuclear Medicine
Monoclonal antibody
Radiolabeled

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Iodine-131 anti-B1 antibody
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014