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

Inclusion Criteria

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