Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells Administered to Patients With Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00893945|
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : December 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors||Drug: DC/AAT Drug: DC/AAT-Flu Drug: DC/KLH||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: DC/AAT vaccine
Intradermal injection of 3 Autologous dendritic cell vaccines (DC/AAT, DC/AAT-flu, DC/KLH) that have been co-cultured with autologous apoptotic tumor specimens.
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.
Other Name: Dendritic cell/autologous apoptotic tumor
Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT
Other Name: dendritic cell/flu-infected autologous apoptotic tumor
Intradermal injection of Autologous dendritic cell vaccine (DC/KLH) which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.
Other Name: dendritic cell/Keyhole Limplet hemocyanin
- Toxicity- assessment of safety and tolerability [ Time Frame: week 0 to week 9 ]
- Measurable disease [ Time Frame: baseline and after completion of vaccination ]
- Activity-monitoring both clinical and immunologic parameters [ Time Frame: week 0 to week 9 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893945
|United States, New York|
|New York, New York, United States, 10065|
|Principal Investigator:||Robert Darnell, MD, PhD||Rockefeller University|