Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493467
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2007-06-27
Brief Title:
Zevalin Ibritumomab Tiuxetan for Early Stage Indolent Lymphomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
Status:
COMPLETED
Status Verified Date:
2022-08
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:
The goal of this clinical research study is to find out if giving Rituxan rituximab with 90Y ibritumomab tiuxetan 90 Y Zevalin may be effective in treating low-grade lymphoma The safety of this combination treatment will also be studied
Detailed Description:
90 Y Zevalin and rituximab are both designed to attach to lymphoma cells causing them to die
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam Blood about 2 to 3 teaspoons and urine will be collected for routine tests You will have a chest x-ray and computerized tomography CT scans of the neck chest abdomen stomach area and pelvis
A PET scan is also recommended A PET Positron Emission Tomography scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body The radioactive solution is either inhaled as a mist or injected into a vein The radioactive solution is usually made from simple sugar that has radioactive particles attached to it After the solution is injected into a vein or inhaled the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs By watching how the solution travels through the body and studying where the solution collects researchers can learn the extent of disease in certain organs in the body
You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart You will have a bone marrow aspirate and biopsy performed To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test
If you are found to be eligible to take part in this study you will be given diphenhydramine Benadryl by vein and you will take acetaminophen Tylenol by mouth before each dose of rituximab This is done to help decrease the risk of developing side effects of rituximab You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment After treatment with rituximab you will then be given 111 In Zevalin this is a radioactive agent that binds to rituximab to help with imaging exams by vein over about 10 minutes This is so researchers can use a special camera to see where the drug is in your body
You will have imaging performed on a camera like an x-ray on either Day 2 or 3 On Day 8 7 days after the first dose of rituximab you will receive a second dose of rituximab You will also be given Benadryl Tylenol and 90Y Zevalin in the same manner as on Day 1
If you experience intolerable side effects while on this study you may be removed from this study Your treatment on the study will end on Day 8
You will return for follow-up tests for 4 years Blood about 2 tablespoons will be drawn weekly for the first 3 months Blood about 2 tablespoons each time will also be drawn at month 6 and 9 of the first year and every 6 months in the second third and fourth years You may also have CT scans PET scans which are recommended x-rays and bone marrow biopsies and aspirates performed if your doctor thinks they are necessary
Your participation on this study will end in about 4 years
This is an investigational study 90 Y Zevalin and rituximab are FDA approved and commercially available Their use in this study is investigational Up to 36 patients will take part in this multicenter study Up to 36 patients will be enrolled at M D Anderson
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam Blood about 2 to 3 teaspoons and urine will be collected for routine tests You will have a chest x-ray and computerized tomography CT scans of the neck chest abdomen stomach area and pelvis
A PET scan is also recommended A PET Positron Emission Tomography scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body The radioactive solution is either inhaled as a mist or injected into a vein The radioactive solution is usually made from simple sugar that has radioactive particles attached to it After the solution is injected into a vein or inhaled the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs By watching how the solution travels through the body and studying where the solution collects researchers can learn the extent of disease in certain organs in the body
You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart You will have a bone marrow aspirate and biopsy performed To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test
If you are found to be eligible to take part in this study you will be given diphenhydramine Benadryl by vein and you will take acetaminophen Tylenol by mouth before each dose of rituximab This is done to help decrease the risk of developing side effects of rituximab You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment After treatment with rituximab you will then be given 111 In Zevalin this is a radioactive agent that binds to rituximab to help with imaging exams by vein over about 10 minutes This is so researchers can use a special camera to see where the drug is in your body
You will have imaging performed on a camera like an x-ray on either Day 2 or 3 On Day 8 7 days after the first dose of rituximab you will receive a second dose of rituximab You will also be given Benadryl Tylenol and 90Y Zevalin in the same manner as on Day 1
If you experience intolerable side effects while on this study you may be removed from this study Your treatment on the study will end on Day 8
You will return for follow-up tests for 4 years Blood about 2 tablespoons will be drawn weekly for the first 3 months Blood about 2 tablespoons each time will also be drawn at month 6 and 9 of the first year and every 6 months in the second third and fourth years You may also have CT scans PET scans which are recommended x-rays and bone marrow biopsies and aspirates performed if your doctor thinks they are necessary
Your participation on this study will end in about 4 years
This is an investigational study 90 Y Zevalin and rituximab are FDA approved and commercially available Their use in this study is investigational Up to 36 patients will take part in this multicenter study Up to 36 patients 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01569 | REGISTRY | NCI CTRP | None |