Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Susan Rudy, MSN
National Institute on Deafness and Other Communication Disorders (NIDCD)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: December 02, 2018

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