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.

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.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck

  * Resectable disease
  * Any stage allowed
* Successfully treated with curative intent
* Recurrent disease allowed provided the following criteria are met:

  * No evidence of disease
  * At least 6 weeks since prior antitumor therapy
* Positive for HLA-A2.1

  * HLA-DR4 allele status known
* Tumor tissue must be available
* No active brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status 0 or 1
* Life expectancy ≥ 6 months
* Granulocyte count \> 2,500/mm\^3
* Lymphocyte count \> 700/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 0.2 mg/dL
* Creatinine \< 0.2 mg/dL
* Hemoglobin \> 8 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after study completion
* No systemic infection or coagulation disorders
* No psychiatric disturbances that would preclude obtaining informed consent or safe conduct of protocol
* HIV negative
* Hepatitis B surface antigen and hepatitis C antibody negative
* No other active malignancies

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 6 weeks since prior adjuvant radiotherapy or chemoradiotherapy

  * No time restriction for prior curative therapy
* No concurrent pharmacological doses of steroids in any form (topical or systemic)