Vaccine Therapy in Treating Patients With Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	UPMC Cancer Centers National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00404339

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	Drug: mutant p53 peptide pulsed dendritic cell vaccine Drug: tetanus toxoid helper peptide Procedure: adjuvant therapy	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
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)

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	50
Study Start Date:	September 2005

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 and older
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

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

Locations

United States, Pennsylvania
UPMC Cancer Centers	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073

Sponsors and Collaborators

UPMC Cancer Centers

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert L. Ferris, MD, PhD

UPMC Cancer Centers

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000515081, PCI-03-156, PCI-0507062
Study First Received:	November 27, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00404339
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Epidermoid carcinoma
Nasopharyngeal carcinoma
Metastatic squamous neck cancer with occult primary
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell

Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Recurrence
Dental Caries
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009