Vaccine Therapy in Treating Patients With Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Intervention
Name: mutant p53 peptide pulsed dendritic cell vaccine Type: Biological
Name: tetanus toxoid helper peptide Type: Biological
Name: adjuvant therapy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Location
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - UPMC Cancer Centers - 412-647-8073
Start Date
September 2005
Sponsors
University of Pittsburgh
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page