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Vaccine Therapy in Treating Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Ferris, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00404339
First received: November 27, 2006
Last updated: April 14, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Head and Neck Cancer
Biological: mutant p53 peptide pulsed dendritic cell vaccine
Biological: tetanus toxoid helper peptide
Procedure: adjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Toxicity profile and overall toxicity rates [ Designated as safety issue: Yes ]
  • Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18 [ Designated as safety issue: No ]
  • Biologic response rate [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2005
Study Completion Date: March 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404339

Locations
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Robert Ferris
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert L. Ferris, MD, PhD University of Pittsburgh
  More Information

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     History of Changes
Obsolete Identifiers: NCT00235612
Other Study ID Numbers: PCI-03-156  CDR0000515081  PCI-0507062 
Study First Received: November 27, 2006
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016