Vaccine Therapy in Treating Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: mutant p53 peptide pulsed dendritic cell vaccine
* Biological: tetanus toxoid helper peptide
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: mutant p53 peptide pulsed dendritic cell vaccine|nan|
|Biological: tetanus toxoid helper peptide|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile and overall toxicity rates |  |  | 
| Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18 |  |  | 
| Biologic response rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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