NCT00455221

Safety Assessment of a Multipeptide-gene Vaccine in CML

Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Leukemia, Myeloid, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Bcr-abl multipeptide vaccine	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
GENETIC	Cytokine gene adjuvant	Cytokine gene adjuvant

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-12-01
• Completion: 2011-11-01
• First posted: 2007-04-03
• Last updated: 2012-06-04

Locations

1 site across 1 country: Iran