Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136422
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2005-08-25
Brief Title:
Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-03
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 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
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
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