Vaccine Therapy in Treating Patients With Head and Neck Cancer

Robert Ferris

Status and phase

Completed

Phase 1

Conditions

Head and Neck Cancer

Treatments

Biological: tetanus toxoid helper peptide

Procedure: adjuvant therapy

Biological: mutant p53 peptide pulsed dendritic cell vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00404339

CDR0000515081 (Registry Identifier)

PCI-0507062

PCI-03-156

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)