Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Biological: 90-Y-ibritumomab tiuxetan
Radiation: indium In 111 ibritumomab tiuxetan
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma|
- To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols. [ Time Frame: up to 4.25 years ] [ Designated as safety issue: No ]
- To add to the overall efficacy and safety experience in this indication. [ Time Frame: up to 4.25 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 1999|
|Study Completion Date:||November 2005|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
Experimental: Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8
For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).
Biological: 90-Y-ibritumomab tiuxetan
IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
Other Name: IDEC-Y2B8Biological: rituximab
Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
Other Name: RituximabRadiation: indium In 111 ibritumomab tiuxetan
IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
Other Name: IDEC-In2B8
OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.
OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005592
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, District of Columbia|
|Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||Mansoor N. Saleh, MD||University of Alabama at Birmingham|