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Vaccine Therapy in Treating Patients With Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mutant p53 peptide pulsed dendritic cell vaccine
tetanus toxoid helper peptide
adjuvant therapy
Sponsored by
Robert Ferris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UPMC Cancer Centers

Outcomes

Primary Outcome Measures

Toxicity profile and overall toxicity rates
Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
Biologic response rate

Secondary Outcome Measures

Full Information

First Posted
November 27, 2006
Last Updated
April 14, 2016
Sponsor
Robert Ferris
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00404339
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Ferris
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
mutant p53 peptide pulsed dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
tetanus toxoid helper peptide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Toxicity profile and overall toxicity rates
Title
Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
Title
Biologic response rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Ferris, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Head and Neck Cancer

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