Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514189
Status:
TERMINATED
Last Update Posted:
2012-07-30
First Post:
2007-08-08
Brief Title:
Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To determine the feasibility of delivering autologous dendritic cells DCs loaded with acute myelogenous leukemia AML lysate plus messenger RNA mRNA to AML patients following consolidation therapy
2 To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA
3 To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA
Secondary Objectives
1 To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilms Tumor-1 gene
2 To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA
1 To determine the feasibility of delivering autologous dendritic cells DCs loaded with acute myelogenous leukemia AML lysate plus messenger RNA mRNA to AML patients following consolidation therapy
2 To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA
3 To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA
Secondary Objectives
1 To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilms Tumor-1 gene
2 To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA
Detailed Description:
Patient Consent Arm 1 - Standard-Dose Consolidation
The vaccine will be made from your AML cells which will be killed frozen and stored away when you start the study When you go into remission researchers will take your normal blood cells and culture them in the laboratory until they become dendritic cells Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease
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 Blood about 1 tablespoon will be drawn to make sure you do not have an infection with HIVAIDS If you do you will not be eligible for this study
If you are found to be eligible to take part in this study AML cells will be collected from your blood through a vein in your arm A blood separator device called an apheresis machine will be used Each apheresis procedure takes about 3-5 hours It is similar to donating platelets to a blood bank During the procedure the blood with tumor cells will be removed and then returned through a second line in the other arm You may have bone marrow aspirations instead with general anesthesia usually lasting up to 3 hours To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After the AML cells are collected you will start receiving your induction and consolidation chemotherapy treatment This treatment is standard of care and is not directly related to your participation in this study After your first cycle of consolidation treatment a bone marrow biopsy will be done to find out if you are in complete remission To collect a bone marrow 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 If you are in complete remission then you will have your normal blood stem cells collected which will be used to make the vaccine All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells Beginning 5 days before the first collection you will receive daily injections under the skin of granulocyte colony stimulating factor G-CSF These are given to increase the number of normal stem cells available for collection On Days 5 and 6 of G-CSF treatment your normal stem cells will be collected They will be taken to the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After you complete the apheresis procedure to collect normal cells you will continue consolidation therapy typically 3-5 cycles The vaccine will be made with your previously frozen cells Once thawed a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an 8-day procedure
After the last consolidation cycle you will begin to receive 4 monthly injections of the vaccine The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy The remaining 3 vaccinations will be given every 28 days - 7 days Once it is ready each vaccine will be injected into a lymph node in your groin A special machine called a sonogram typically used to look at babies in the womb will be used to painlessly locate exactly where the injection should go
About 3-7 days after each vaccine about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine This will be done with a small injection under the skin on your forearm About 48 hours later researchers will measure the area around the injection for redness which would be a sign that your immune system is reacting to the vaccine
After you have received all 4 vaccines you will be seen in the clinic yearly to evaluate how you tolerated the vaccines
Routine long-term follow-up exams will be performed by your leukemia doctor as per standard of care
This is an investigational study The vaccines are not commercially available and only authorized for use in research A total of 40 patients will take part in this study All will be enrolled at M D Anderson
Patient Consent Arm 2 - Autologous Peripheral Blood Progenitor Cell Consolidation
The vaccine will be made from your AML cells which will be killed frozen and stored away when you start the study When you go into remission researchers will take your normal blood cells and culture them in the laboratory until they become dendritic cells Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease
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 Blood about 1 tablespoon will be drawn to make sure you do not have an infection with HIVAIDS If you do you will not be eligible for this study
If you are found to be eligible to take part in this study AML cells will be collected from your blood through a vein in your arm A blood separator device called an apheresis machine will be used Each apheresis procedure takes about 3-5 hours It is similar to donating platelets to a blood bank You may have bone marrow aspirations instead with general anesthesia usually lasting up to 3 hours To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After the AML cells are collected you will start receiving your induction and consolidation chemotherapy treatment This treatment is standard of care and is not directly related to your participation in this study After your first cycle of consolidation treatment a bone marrow biopsy will be done to find out if you are in complete remission To collect a bone marrow 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 If you are in complete remission then you will have your normal blood stem cells collected which will be used to make the vaccine All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells Beginning 5 days before the first collection you will receive daily injections under the skin of granulocyte colony stimulating factor G-CSF These are given to increase the number of normal stem cells available for collection On Days 5 and 6 of G-CSF treatment your normal stem cells will be collected They will be taken to the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After you complete the apheresis procedure to collect normal cells you will continue consolidation therapy with high-dose standard busulfan and cyclophosphamide chemotherapy You will also have an autologous peripheral blood progenitor cell transplant The chemotherapy and transplant are standard of care
After the chemotherapy and transplant when your blood counts have recovered you will begin to receive 4 monthly injections of the vaccine The vaccine will be made with your previously frozen cells Once thawed a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an eight day procedure
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy The remaining 3 vaccinations will be given every 28 days - 7 days Once it is ready each vaccine will be injected into a lymph node in your groin A special machine called a sonogram typically used to look at babies in the womb will be used to painlessly locate exactly where the injection should go
About 3-7 days after each vaccine about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine This will be done with a small injection under the skin on your forearm About 48 hours later researchers will measure the area around the injection for redness which would be a sign that your immune system is reacting to the vaccine
After you have received all 4 vaccines you will be seen in the clinic to evaluate how you tolerated the vaccines
Routine long-term follow-up exams will be performed by your leukemia doctor yearly as per standard of care
This is an investigational study The vaccines are not commercially available and only authorized for use in research A total of 20 patients take part in this study All will be enrolled at M D Anderson
The vaccine will be made from your AML cells which will be killed frozen and stored away when you start the study When you go into remission researchers will take your normal blood cells and culture them in the laboratory until they become dendritic cells Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease
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 Blood about 1 tablespoon will be drawn to make sure you do not have an infection with HIVAIDS If you do you will not be eligible for this study
If you are found to be eligible to take part in this study AML cells will be collected from your blood through a vein in your arm A blood separator device called an apheresis machine will be used Each apheresis procedure takes about 3-5 hours It is similar to donating platelets to a blood bank During the procedure the blood with tumor cells will be removed and then returned through a second line in the other arm You may have bone marrow aspirations instead with general anesthesia usually lasting up to 3 hours To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After the AML cells are collected you will start receiving your induction and consolidation chemotherapy treatment This treatment is standard of care and is not directly related to your participation in this study After your first cycle of consolidation treatment a bone marrow biopsy will be done to find out if you are in complete remission To collect a bone marrow 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 If you are in complete remission then you will have your normal blood stem cells collected which will be used to make the vaccine All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells Beginning 5 days before the first collection you will receive daily injections under the skin of granulocyte colony stimulating factor G-CSF These are given to increase the number of normal stem cells available for collection On Days 5 and 6 of G-CSF treatment your normal stem cells will be collected They will be taken to the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After you complete the apheresis procedure to collect normal cells you will continue consolidation therapy typically 3-5 cycles The vaccine will be made with your previously frozen cells Once thawed a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an 8-day procedure
After the last consolidation cycle you will begin to receive 4 monthly injections of the vaccine The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy The remaining 3 vaccinations will be given every 28 days - 7 days Once it is ready each vaccine will be injected into a lymph node in your groin A special machine called a sonogram typically used to look at babies in the womb will be used to painlessly locate exactly where the injection should go
About 3-7 days after each vaccine about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine This will be done with a small injection under the skin on your forearm About 48 hours later researchers will measure the area around the injection for redness which would be a sign that your immune system is reacting to the vaccine
After you have received all 4 vaccines you will be seen in the clinic yearly to evaluate how you tolerated the vaccines
Routine long-term follow-up exams will be performed by your leukemia doctor as per standard of care
This is an investigational study The vaccines are not commercially available and only authorized for use in research A total of 40 patients will take part in this study All will be enrolled at M D Anderson
Patient Consent Arm 2 - Autologous Peripheral Blood Progenitor Cell Consolidation
The vaccine will be made from your AML cells which will be killed frozen and stored away when you start the study When you go into remission researchers will take your normal blood cells and culture them in the laboratory until they become dendritic cells Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease
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 Blood about 1 tablespoon will be drawn to make sure you do not have an infection with HIVAIDS If you do you will not be eligible for this study
If you are found to be eligible to take part in this study AML cells will be collected from your blood through a vein in your arm A blood separator device called an apheresis machine will be used Each apheresis procedure takes about 3-5 hours It is similar to donating platelets to a blood bank You may have bone marrow aspirations instead with general anesthesia usually lasting up to 3 hours To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After the AML cells are collected you will start receiving your induction and consolidation chemotherapy treatment This treatment is standard of care and is not directly related to your participation in this study After your first cycle of consolidation treatment a bone marrow biopsy will be done to find out if you are in complete remission To collect a bone marrow 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 If you are in complete remission then you will have your normal blood stem cells collected which will be used to make the vaccine All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells Beginning 5 days before the first collection you will receive daily injections under the skin of granulocyte colony stimulating factor G-CSF These are given to increase the number of normal stem cells available for collection On Days 5 and 6 of G-CSF treatment your normal stem cells will be collected They will be taken to the M D Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine
After you complete the apheresis procedure to collect normal cells you will continue consolidation therapy with high-dose standard busulfan and cyclophosphamide chemotherapy You will also have an autologous peripheral blood progenitor cell transplant The chemotherapy and transplant are standard of care
After the chemotherapy and transplant when your blood counts have recovered you will begin to receive 4 monthly injections of the vaccine The vaccine will be made with your previously frozen cells Once thawed a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an eight day procedure
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy The remaining 3 vaccinations will be given every 28 days - 7 days Once it is ready each vaccine will be injected into a lymph node in your groin A special machine called a sonogram typically used to look at babies in the womb will be used to painlessly locate exactly where the injection should go
About 3-7 days after each vaccine about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine This will be done with a small injection under the skin on your forearm About 48 hours later researchers will measure the area around the injection for redness which would be a sign that your immune system is reacting to the vaccine
After you have received all 4 vaccines you will be seen in the clinic to evaluate how you tolerated the vaccines
Routine long-term follow-up exams will be performed by your leukemia doctor yearly as per standard of care
This is an investigational study The vaccines are not commercially available and only authorized for use in research A total of 20 patients 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