Vaccine Therapy in Treating Patients With Head and Neck Cancer

Phase 1

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00404339
• Lead Sponsor: Robert Ferris

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Primary Completion: 2011-03
• Study Completion: 2014-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
Biologic response rate
Toxicity profile and overall toxicity rates

Trial Locations

Locations (1)

UPMC Cancer Centers; 🇺🇸 Pittsburgh, Pennsylvania, United States