Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)
- Determine the toxicity of intranodally injected autologous dendritic cells (DC) loaded
with wild-type p53 peptides with or without T-helper peptide epitope in patients with
squamous cell carcinoma of the head and neck.
- Determine the local and systemic immunomodulatory effects of this vaccine in these
OUTLINE: This is a randomized, pilot study.
Patients undergo leukapheresis. The resulting dendritic cells (DC) are pulsed with wild-type
(wt) p53 peptides with or without T-helper (Th) peptides. Individual autologous vaccines are
prepared for each patient. Patients who are HLA-A2-DR4-negative are randomized to 1 of 2
treatment arms (arm I or arm II). Patients who are HLA-A2-DR4-positive are assigned to arm
- Arm I: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides
- Arm II: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides
and Th tetanus toxoid peptide.
- Arm III (HLA-A2-DR4-positive patients only): Patients receive autologous DC loaded with
HLA-A2.1-restricted wt p53 peptides and Th wt p53 peptide.
In all arms, each vaccine is administered by ultrasonography-guided inguinal intranodal
injection over 30 minutes on days 0, 14, and 28.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Toxicity profile and overall toxicity rates
Robert L. Ferris, MD, PhD
University of Pittsburgh
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|