Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed & Refractory Mantle Cell Lymphoma
Drug: Yttrium-ibritumomab (Zevalin)
|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 II Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma|
- Number of Participants with Objective tumor response [ Time Frame: Followed for 4 years or until disease progression ] [ Designated as safety issue: No ]Objective tumor response is defined as CR + CCR + PR, where CR = Complete Response, CCR = Clinical Complete Response and PR = partial response. All patients who receive any dose of Zevalin will be included in the calculation of response rate.
|Study Start Date:||April 2002|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Yttrium-ibritumomab (Zevalin)
After Rituximab infusion (250 mg/m^2 intravenous) on Day 1, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Drug: Yttrium-ibritumomab (Zevalin)
After Rituximab infusion, 111^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Other Names:Drug: Rituximab
250 mg/m^2 in the vein over 6 to 8 hours on Day 1.
Other Name: Rituxan
Mantle cell lymphoma cell express a protein called CD20. Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium. The radioactivity will be delivered to the cancer cells by the antibody will help killing the mantle cell lymphoma cells. Before treatment starts, patients will have a physical exam, including blood and urine test. Patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken with a large needle. A cardiogram (EKG) will be performed before therapy and after 1 and 3 months of therapy.
Patients in this study will receive one dose of rituximab in the vein over 6 to 8 hours on the first day of treatment. This will be followed by an infusion of antibody labeled with radioactive indium, which will allow imaging of the tumor sites and normal tissue site that will bind the antibody.
Imaging will be performed twice in the nuclear medicine department of Day 1, and once on either Day 2 or 3. On day 8 (7 days after the first dose of rituximab), patients will receive a second dose of rituximab. This will immediately be followed by a dose of Ibritumomab tiuxetan given by vein over ten minutes. Patients will receive diphenhydramine (Benadryl) by vein and mouth and acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to prevent fever and chills. All treatments will be given in an outpatient setting.
Blood test will be taken weekly during the first 3 months, the every 3 months for 1 year, and then every 6 months for 3 years. CT scans, x-rays, and bone marrow biopsies will be repeated if needed after 3 months of therapy and every 3 months for 1 years, then every 6 months for 3 years. If tumors do not shrink after 3 months of therapy or increase in size, patients will be offered a different treatment.
This is an investigational study. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038623
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anas Younes, MD||UT MD Anderson Cancer Center|