Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038623
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2002-06-03
Brief Title:
Study Of Yttrium-ibritumomab Zevalin For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study Of Yttrium-ibritumomab Zevalin For the Treatment Of Patients With Relapsed And Refractory Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study of Yttrium-ibritumomab Zevalin For the treatment of Patients with Relapsed Refractory Mantle Cell Lymphoma
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None