Vaccine Therapy in Treating Patients With Head and Neck Cancer

NCT00404339 | Completed Phase 1

• 3 other identifiers: PCI-03-156CDR0000515081PCI-0507062
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (3)

• Toxicity profile and overall toxicity rates

• Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18

• Biologic response rate

Interventions

mutant p53 peptide pulsed dendritic cell vaccine BIOLOGICAL

tetanus toxoid helper peptide BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Robert Ferris: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Robert L. Ferris, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: UPMC Endowed Professor and Chief, Division of Head and Neck Surgery, Department of Otolaryngology

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2014
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

US (1)