Phase I Evaluation of Semi-continuous Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer
Dendritic cell (DC)-based vaccination, usually administered by a traditional intradermal
route, is a new treatment option for cancer patients. While the previous DC-based
vaccination trials have shown the safety of this approach and its ability to induce
objective clinical responses, the overall efficacy of DC-based vaccines is still
disappointing (Rosenberg et al., 2004). We hypothesize that the two likely causes of such
limited clinical activity are: A) suboptimal type of DCs used as a vaccine and B) suboptimal
modes of use of such vaccines that do not allow the vaccinated patients to fully benefit
from DC biology.
We will conduct a pilot evaluation of the therapeutic vaccination with DC1s loaded with
autologous tumor material, in patients with metastatic colorectal cancer that have been
resected to no or minimal evidence of disease.The proposed evaluation of the novel
intralymphatic route of DC-based vaccination will allow us to administer the vaccine in a
way that is more physiologic with respect to the kinetics of antigen appearance to the lymph
nodes and is feasible to be performed in repetitive fashion, without damaging local lymph
nodes.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
The primary endpoint of this study is to evaluate the feasibility and safety of semi-continuous intralymphatic vaccination dendritic cells.
4 to 14 weeks
Yes
David L. Bartlett, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
05-063
NCT00558051
January 2008
July 2014
Name | Location |
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University of Cancer Institute | Pittsburgh, Pennsylvania 15232 |