Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine
This study is being conducted to determine the efficacy, side effects, and toxicity of an investigational vaccine that consists of tumor-pulsed dendritic cells administered with an immune stimulating drug called interleukin-2 (IL-2). Dendritic cells are immune cells that are obtained from a subject's blood and are important in the body’s immune response to foreign substances. This study will examine the response of a subject's immune system after receiving several vaccinations containing their own dendritic cells which have been exposed to dead fragments of their cancer cells in the laboratory. This may result in sensitizing a subject's dendritic cells to their cancer cells so that their dendritic cells will react with other cells of the immune system and attack the cancer. It has been shown in the laboratory that dendritic cells exposed to cancer cell fragments can provide lymphocytes (a type of white blood cell) with signals they require in order to become fully activated and acquire the ability to kill cancer cells.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Assessing Autologous, Tumor-Pulsed Dendritic Cells as a Tumor Vaccine Administered With IL-2 in Patients With Metastatic Colorectal Cancer|
- To assess the antitumor response of this immunotherapy regimen.
- To characterize the immune response (as defined in Section VII) to the tumor-pulsed dendritic cell vaccine combined with IL-2 administration in patients with metastatic colorectal cancer.
- To evaluate the toxicity of this treatment regimen.
|Study Start Date:||March 2000|
|Estimated Study Completion Date:||May 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176761
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Zalupski, M.D.||University of Michigan Cancer Center|