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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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)


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Toxicity profile and overall toxicity rates

Safety Issue:

Yes

Principal Investigator

Robert L. Ferris, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000515081

NCT ID:

NCT00404339

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • tongue cancer
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232