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
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
The length of time on this study depends upon the number of vaccines available and whether
or not unacceptable side effects occur.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
Daniel J. DeAngelo, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|