Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021424
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
April 30, 2015
June 2001
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Complete list of historical versions of study NCT00021424 on Archive Site
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Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer.


  • Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases.
  • Determine the safety profile of this regimen in these patients.
  • Determine the clinical activity of this regimen, in terms of inflammation at injection site(s) and disease regression or stabilization, in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks 0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Metastatic Cancer
Biological: recombinant fowlpox-TRICOM vaccine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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  • Histologically confirmed stage IV squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases for which current available treatment is not likely to offer a survival advantage or result in significant palliation

    • Unresectable locoregional recurrence after maximum radiotherapy OR
    • Local disease with unresectable distant metastases involving:

      • Base of skull
      • Prevertebral fascia
      • Deep neck muscles
      • Carotid artery (requiring resection)
      • Nasopharynx and/or pterygoid muscles
  • Ineligible to receive radiotherapy to head and neck during study
  • Primary intraoral lesions must be measurable and accessible to intralesional injections
  • No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease



  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 2 months


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8 g/dL


  • Bilirubin less than 1.5 mg/dL
  • AST/ALT less than 4 times upper limit of normal (ULN)
  • PT/PTT less than 1.5 times ULN


  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No evidence of congestive heart failure
  • No serious cardiac dysrhythmia
  • No evidence of recent prior myocardial infarction on EKG
  • No clinical coronary artery disease


  • No history of seizures or concurrent seizure disorder
  • No evidence of encephalitis, multiple sclerosis, or other structural brain lesion(s) by clinical or radiological evaluation


  • No risk of immune system compromise
  • HIV negative
  • No hypersensitivity to eggs
  • No significant history of allergies (e.g., anaphylaxis or angioedema)


  • No active or chronic infection
  • No other serious concurrent medical illness
  • No other malignancy unless previously treated with curative intent and no evidence of persistent or recurrent disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • No more than 2 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent systemic corticosteroids


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of nodal groups


  • More than 4 weeks since prior surgery for primary or metastatic lesions and recovered
  • No prior splenectomy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institute on Deafness and Other Communication Disorders (NIDCD)
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Study Chair: Susan Rudy, MSN National Institute on Deafness and Other Communication Disorders (NIDCD)
National Cancer Institute (NCI)
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP