Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
NCT ID: NCT00514189
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2007-07-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 Wilm's 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 HIV/AIDS. 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 HIV/AIDS. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Autologous Dendritic Cells
Autologous Dendritic Cells
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous Dendritic Cells
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients must have \>/= 2,000 circulating blasts/ul peripheral blood or \>/= 50% blasts in bone marrow biopsy
3. Performance Status 0-2
Exclusion Criteria
2. Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
3. History of systemic autoimmune disease
4. Positive antibody to human immunodeficiency virus
5. Patients with Acute promyelocytic Leukemia are not eligible for this study.
6. Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17)
7. Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chitra M. Hosing, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-0379
Identifier Type: -
Identifier Source: org_study_id