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.
- 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
- No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease
- 18 and over
- Zubrod 0-2
- 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
PRIOR CONCURRENT 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
- 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