Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267085
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2005-12-19
Brief Title:
Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia CML and Minimal Residual Disease
Status:
COMPLETED
Status Verified Date:
2012-08
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 learn if giving 1 of 2 CML Chronic Myeloid Leukemia vaccines CML-VAX B2 or CML-VAX B3 together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate but who still have small amounts of detectable disease
Detailed Description:
Patients who are eligible to take part in this study have already responded well to treatment with imatinib mesylate Your disease is in what is called a complete cytogenetic remission ie The Philadelphia chromosome is no longer detectable However there is still a small amount of disease that can be detected using the most sensitive techniques available CML-VAX B2 and CML-VAX B3 are experimental vaccines made from the proteins that cause leukemia cells in CML to behave abnormally Imatinib mesylate is the standard therapy for CML and blocks the function of this protein
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam and medical history Blood about 2 tablespoons will be collected for routine tests You will also have a bone marrow aspiration and a chromosome analysis of the number of chromosomes in the bone marrow To collect a bone marrow aspiration an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test
You will also have some additional blood work about 1 tablespoon to test the levels of leukemia in your blood If you agree to participate in this study this test will be repeated 2 more times about 2 weeks apart before you can start vaccination This is done to get a good measure of the amount of disease you may have
There are 2 different vaccines that can be used in this study CML-VAX B2 and CML-VAX B3 If you are found to be eligible to take part in this study you will only receive one of them Which one you receive depends on the type of protein your leukemia makes as these vaccines are specific to each of the 2 most common proteins that may be produced by CML cells
All participants in this study will receive 1 of the 2 vaccines as well as imatinib mesylate Imatinib mesylate will continue to be given to you at the dose that you are taking now The vaccines will be mixed with a substance called montanide This is a standard procedure with vaccines and is done to try to make it more likely that you will have a good immune response to the vaccines in general
When the appropriate vaccine is selected for your use you will receive an injection of the vaccine once every 2 weeks for the first 8 weeks once 3 weeks later and then once every month for a total of 15 vaccines in 12 months You will receive the vaccine at M D Anderson The vaccine will be injected in the arms or the thighs Two days before each vaccination and again the day of each vaccination you will receive an injection of a growth hormone called GM-CSF Leukine The purpose of this injection is to boost your immune system in response to the vaccine to specifically kill your leukemia This injection is given through a small needle and injected under your skin in your arms or your thighs You can be taught how to do this for yourself but you may choose to have it given to you by a member of the study staff
Every time that you come in for an injection of the vaccine you will also have a physical exam and have routine blood work done about 2 tablespoons Every 3 months while receiving the vaccine you will also have blood drawn about 1 tablespoon to test the level of leukemia and to see if you are responding to the vaccine
You will be taken off study if intolerable side effects occur or your disease comes out of remission About 2 weeks after the last injection of vaccine you will have blood drawn about 1 tablespoon to test the level of leukemia and to see if you are responding
This is an investigational study CML-VAX B2 and CML-VAX B3 are not FDA approved The vaccine and montanide will be free Because you are receiving imatinib mesylate as part of your standard of care you andor your insurance company or third-party payer will be responsible for the costs of it If GM-CSF is not covered by your insurance or other third-party payer it will be provided free of charge A maximum of 60 patients will take part in this study A maximum of 20 will be enrolled at M D Anderson
Optional Procedures If you agree additional blood tests about 3 tablespoons each will be done at about 30 days before the first vaccine after 6 months and 9 months from the start of vaccination and about 10 tablespoons each on the day of the first vaccine and after 3 months and 2 weeks after the last vaccine to measure the response of your immune system to the vaccine
If you agree a skin test will be done where a small amount of the proteins will be injected under your skin for another measure of response of your immune system If a small nodule develops in the area where you receive this injection it may represent an immune response This will be measured by your doctor or your nurse
You do not have to agree to take part in the optional procedures in order to receive treatment on this study
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam and medical history Blood about 2 tablespoons will be collected for routine tests You will also have a bone marrow aspiration and a chromosome analysis of the number of chromosomes in the bone marrow To collect a bone marrow aspiration 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
You will also have some additional blood work about 1 tablespoon to test the levels of leukemia in your blood If you agree to participate in this study this test will be repeated 2 more times about 2 weeks apart before you can start vaccination This is done to get a good measure of the amount of disease you may have
There are 2 different vaccines that can be used in this study CML-VAX B2 and CML-VAX B3 If you are found to be eligible to take part in this study you will only receive one of them Which one you receive depends on the type of protein your leukemia makes as these vaccines are specific to each of the 2 most common proteins that may be produced by CML cells
All participants in this study will receive 1 of the 2 vaccines as well as imatinib mesylate Imatinib mesylate will continue to be given to you at the dose that you are taking now The vaccines will be mixed with a substance called montanide This is a standard procedure with vaccines and is done to try to make it more likely that you will have a good immune response to the vaccines in general
When the appropriate vaccine is selected for your use you will receive an injection of the vaccine once every 2 weeks for the first 8 weeks once 3 weeks later and then once every month for a total of 15 vaccines in 12 months You will receive the vaccine at M D Anderson The vaccine will be injected in the arms or the thighs Two days before each vaccination and again the day of each vaccination you will receive an injection of a growth hormone called GM-CSF Leukine The purpose of this injection is to boost your immune system in response to the vaccine to specifically kill your leukemia This injection is given through a small needle and injected under your skin in your arms or your thighs You can be taught how to do this for yourself but you may choose to have it given to you by a member of the study staff
Every time that you come in for an injection of the vaccine you will also have a physical exam and have routine blood work done about 2 tablespoons Every 3 months while receiving the vaccine you will also have blood drawn about 1 tablespoon to test the level of leukemia and to see if you are responding to the vaccine
You will be taken off study if intolerable side effects occur or your disease comes out of remission About 2 weeks after the last injection of vaccine you will have blood drawn about 1 tablespoon to test the level of leukemia and to see if you are responding
This is an investigational study CML-VAX B2 and CML-VAX B3 are not FDA approved The vaccine and montanide will be free Because you are receiving imatinib mesylate as part of your standard of care you andor your insurance company or third-party payer will be responsible for the costs of it If GM-CSF is not covered by your insurance or other third-party payer it will be provided free of charge A maximum of 60 patients will take part in this study A maximum of 20 will be enrolled at M D Anderson
Optional Procedures If you agree additional blood tests about 3 tablespoons each will be done at about 30 days before the first vaccine after 6 months and 9 months from the start of vaccination and about 10 tablespoons each on the day of the first vaccine and after 3 months and 2 weeks after the last vaccine to measure the response of your immune system to the vaccine
If you agree a skin test will be done where a small amount of the proteins will be injected under your skin for another measure of response of your immune system If a small nodule develops in the area where you receive this injection it may represent an immune response This will be measured by your doctor or your nurse
You do not have to agree to take part in the optional procedures in order to receive treatment on this study
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