Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells Administered to Patients With Brain Tumors
This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer.
This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify foreign material in the body (such as bacteria, viruses, or tumor cells).
When DCs recognize this material, they use it to activate other cells of the immune system to mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology, each participant's DCs will be loaded with samples of their own tumor cells that were obtained at surgical resection. These tumor cells are killed in the laboratory using a special protocol, and then "fed" to the DCs. The DCs "eat" this material, and these "fed" DCs make up the vaccine.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors|
- Toxicity- assessment of safety and tolerability [ Time Frame: week 0 to week 9 ] [ Designated as safety issue: Yes ]
- Measurable disease [ Time Frame: baseline and after completion of vaccination ] [ Designated as safety issue: No ]
- Activity-monitoring both clinical and immunologic parameters [ Time Frame: week 0 to week 9 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: DC/ATT vaccine
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor specimens.
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.Drug: DC/AAT-Flu
Autologous dendritic cells which have been co-cultured with AAT that has been infected with temperature sensitive influenza virus ("FluMist") prior to induction of apoptotic death.Drug: DC/KLH
Autologous dendritic cells which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.
If you are eligible, and you decide to join this research study, you will get two to three shots of the experimental vaccine, each three weeks apart.
You will then have a follow up period where we will monitor you and your medical records for any affects of the experimental treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893945
|United States, New York|
|New York, New York, United States, 10065|
|Principal Investigator:||Robert Darnell, MD, PhD||Rockefeller University|