Spots Global Cancer Trial Database for Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial