OBJECTIVES:

• Determine the maximum tolerated dose (MTD) of PV701 administered by direct intratumoral injection in patients with advanced or recurrent unresectable squamous cell carcinoma of the head and neck.
• Determine the toxicity of intratumoral PV701 in these patients.
• Determine response rate and time to progression at the injection site in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive intratumoral PV701 once weekly for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PV701 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 6-10 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

  • Locally advanced or recurrent disease
  • Distant metastases in addition to locally advanced disease acceptable
• Not amenable to available standard treatment or palliative measures
• At least one target lesion accessible for intratumoral injection, less than 4 cm, and not situated near an airway or major artery
• Tumor volume(s) must be large enough to receive injection
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Hemoglobin > 10 g/dL (transfusion permitted)
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 2 times upper limit of normal (ULN)
• AST/ALT ≤ 2.5 times ULN

Renal

• Creatinine < 2.5 mg/dL

Cardiovascular

• No uncontrolled symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• No history of significantly compromised pulmonary function (i.e. FEV_1 < 50% of predicted) or decreased oxygen saturation of < 95% on room air

Other

• No history of allergy to eggs or egg-based or chicken embryo-based vaccines
• No frequent contact with immunocompromised individuals
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No history of diabetes mellitus requiring oral hypoglycemic agents or insulin
• No HIV-positive patients receiving combination antiretroviral therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• More than 4 weeks since prior surgery and recovered

Other

• No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy
• No concurrent antiviral therapy