Vaccine Therapy in Treating Patients With Head and Neck Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00404339 |
Recruitment Status :
Completed
First Posted : November 28, 2006
Last Update Posted : April 18, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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 |
Responsible Party: | Robert Ferris, UPMC Endowed Professor and Chief, Division of Head and Neck Surgery, Department of Otolaryngology, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00404339 |
Obsolete Identifiers: | NCT00235612 |
Other Study ID Numbers: |
PCI-03-156 CDR0000515081 ( Registry Identifier: PDQ (Physician Data Query) ) PCI-0507062 |
First Posted: | November 28, 2006 Key Record Dates |
Last Update Posted: | April 18, 2016 |
Last Verified: | April 2016 |
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 |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |