Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Head and Neck Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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