Vaccine Therapy in Treating Patients With Head and Neck Cancer
RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.
Head and Neck Cancer
Biological: mutant p53 peptide pulsed dendritic cell vaccine
Biological: tetanus toxoid helper peptide
Procedure: adjuvant therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Toxicity profile and overall toxicity rates [ Designated as safety issue: Yes ]
- Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18 [ Designated as safety issue: No ]
- Biologic response rate [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- 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 patients.
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 III.
- Arm I: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides only.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404339
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Robert L. Ferris, MD, PhD||University of Pittsburgh|