Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455221
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2007-03-31
Brief Title:
Safety Assessment of a Multipeptide-gene Vaccine in CML
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
Status:
COMPLETED
Status Verified Date:
2012-05
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 primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment
We will also perform some laboratory tests suggesting biological response
We will also perform some laboratory tests suggesting biological response
Detailed Description:
Patients will continue to take their current dose of Imatinib
Patients will undergo HLA-typing to define the HLA A B and DR
One constant dose of ten bcr-abl peptides 100μg each will be administered subcutaneously in all patients triweekly for 8 doses
Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination
The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids If this is well tolerated then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid If this is well tolerated then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids If this is well tolerated then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids Once assigned to a dose the patient will receive the same dose throughout their participation in this trial
Each vaccination may consist of one to several shots placed under the skin on the forearm thigh or trunk area and the sites will rotate per vaccination
During the clinic visit for vaccinations blood tests will be drawn If during the course of therapy side effects develop that the doctor feels pose a threat to the patient treatment will be stopped
Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site
Patients lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation
During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by
1 doing a bone marrow biopsy and aspirate analysis and
2 measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients peripheral blood and bone marrow aspirate
Patients will undergo HLA-typing to define the HLA A B and DR
One constant dose of ten bcr-abl peptides 100μg each will be administered subcutaneously in all patients triweekly for 8 doses
Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination
The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids If this is well tolerated then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid If this is well tolerated then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids If this is well tolerated then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids Once assigned to a dose the patient will receive the same dose throughout their participation in this trial
Each vaccination may consist of one to several shots placed under the skin on the forearm thigh or trunk area and the sites will rotate per vaccination
During the clinic visit for vaccinations blood tests will be drawn If during the course of therapy side effects develop that the doctor feels pose a threat to the patient treatment will be stopped
Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site
Patients lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation
During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by
1 doing a bone marrow biopsy and aspirate analysis and
2 measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients peripheral blood and bone marrow aspirate
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