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(RDA-0611) Study of Autologous Dendritic Cells Pulsed with Autologous Apoptotic Tumor Cells Administered to Cancer Patients with Brain Tumors


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A Phase I Study of Autologous Dendritic Cells Pulsed with Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients with Brain Tumors. (RDA-0611)

Principal Investigator:
Robert B. Darnell M.D., Ph.D.

Investigators:

Contact Information:
Mayu Frank, ANP
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: (212) 327-7443
Email: frankm@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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.



Detailed Description of Protocol:
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.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:



- Pathologically confirmed brain tumors

- Brain cancer that is no longer responsive to conventional therapy

- You have had a surgical resection of tumor that our laboratory has deemed suitable for vaccine preparation.

- You must be able to defer chemotherapy for 6 to 9 weeks

Gender:
Both

Age(s):
18 years and older

Children permitted to participate:
No

Potential Benefits.....
This is a research study, and the potential benefit of this vaccine as a cancer treatment is entirely unknown, and there may not be any benefits of this vaccine to you.

There is a chance that you may be more resistant (immune) to the flu after this study, but this is not certain, so that it should not affect your decision to obtain flu shots in the future.



Compensation:
If research done on your samples helps develop a drug or another product that is sold to the public, the University and the researcher may share in some of the profits. For example, a cell line from your samples could be used to make a product for sale. The university does not plan to pay you any money resulting from such discoveries. However, by consenting to this study, you do not give up any rights you may have.