Vaccine Therapy in Treating Patients With Head and Neck Cancer

Robert Ferris17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

mutant p53 peptide pulsed dendritic cell vaccineBIOLOGICAL

tetanus toxoid helper peptideBIOLOGICAL

adjuvant therapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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)

Locations (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Toxicity profile and overall toxicity rates

Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18

Biologic response rate

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.