Vaccine Therapy in Treating Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00404339|
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : April 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: mutant p53 peptide pulsed dendritic cell vaccine Biological: tetanus toxoid helper peptide Procedure: adjuvant therapy||Phase 1|
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2014|
- Toxicity profile and overall toxicity rates
- Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
- Biologic response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404339
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Robert L. Ferris, MD, PhD||University of Pittsburgh|