NCT00404339

Vaccine Therapy in Treating Patients With Head and Neck Cancer

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Robert Ferris · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	mutant p53 peptide pulsed dendritic cell vaccine
BIOLOGICAL	tetanus toxoid helper peptide
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2005-09-01
• Primary completion: 2011-03-01
• Completion: 2014-03-01
• First posted: 2006-11-28
• Last updated: 2016-04-18

Locations

1 site across 1 country: United States