Vaccine Therapy in Treating Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): mutant p53 peptide pulsed dendritic cell vaccine; tetanus toxoid helper peptide; adjuvant therapy
Intervention type(s): Biological; Biological; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; tongue cancer