Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myelodysplasia or acute myelogenous leukemia.
Acute Myelogenous Leukemia
Biological: autologous tumor cells
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I Study of Vaccination With Lethally Irradiated, Autologous Acute Myeloblastic Leukemia Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Colony Stimulating Factor in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia|
- To determine the feasibility of preparing lethally irradiated autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with myelodysplastic syndromes (MDS) or AML
- To determine the safety and biologic activity of vaccination with lethally irradiated, autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with MDS or AML
|Study Start Date:||January 2000|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
This study will make use of leukemic myeloblasts harvested by bone marrow aspirate in patients with myelodysplasia and acute myelogenous leukemia. These harvested tumor cells will be modified by adenoviral mediated gene transfer to secrete granulocyte-macrophage colony stimulating factor (GM-CSF).
Patients will be administered vaccines at one of three dose levels (as determined by total cell yield). Vaccinations will be given weekly for three weeks, followed by every other week until the vaccine supply is exhausted or when patients are removed from the study.
The patient will receive a minimum of six vaccinations, but more will be administered if the vaccine is available.
During the course of the study, patients will be tested to see how their immune system is reacting to the vaccinations. Testing will include bloodwork evaluating the immune cells in the body at monthly intervals. Skin biopsies may also be performed to see if an immune reaction is occuring at the injection site.
During the first course of treatment, a bone marrow biopsy and aspirate may be performed monthly.
The length of time on this study depends upon the number of vaccines available and whether or not unacceptable side effects occur.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136422
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel J. DeAngelo, MD, PhD||Dana-Farber Cancer Institute|