Vaccine Therapy in Treating Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00404339
• Other study ID #: CDR0000515081
• Secondary ID: PCI-03-156PCI-05
• Status: Recruiting
• Phase: Phase 1
• First received: November 27, 2006
• Last updated: February 26, 2011
• Start date: September 2005

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00235612

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• mutant p53 peptide pulsed dendritic cell vaccine

• tetanus toxoid helper peptide

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity profile and overall toxicity rates			Yes
Primary	Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18			No
Primary	Biologic response rate			No