Clinical trial NCT00404339: Vaccine Therapy in Treating Patients With Head and Neck Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Toxicity profile and overall toxicity rates
measure: Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
measure: Biologic response rate
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robert L. Ferris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: