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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Head and Neck Cancer, Metastatic Cancer

Intervention / Treatment
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* Biological: recombinant fowlpox-TRICOM vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8 g/dL Hepatic: 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 Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No evidence of congestive heart failure No serious cardiac dysrhythmia No evidence of recent prior myocardial infarction on EKG No clinical coronary artery disease Neurologic: 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 Immunologic: No risk of immune system compromise HIV negative No hypersensitivity to eggs No significant history of allergies (e.g., anaphylaxis or angioedema) Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: 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 Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 50% of nodal groups Surgery: More than 4 weeks since prior surgery for primary or metastatic lesions and recovered No prior splenectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant fowlpox-TRICOM vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, skin metastases