A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma

Date de début de l'étude : 1 avril 2004

Inclusion Criteria: * 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 * Performance status - ECOG 0-2 * More than 3 months * WBC \>= 3,000/mm\^3 * Hemoglobin \> 10 g/dL (transfusion permitted) * Platelet count \>= 100,000/mm\^3 * Bilirubin \< 2 times upper limit of normal (ULN) * AST/ALT =\< 2.5 times ULN * Creatinine \< 2.5 mg/dL * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No history of significantly compromised pulmonary function (i.e. FEV_1 \< 50% of predicted) or decreased oxygen saturation of \< 95% on room air * 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 * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior radiotherapy and recovered * More than 4 weeks since prior surgery and recovered * No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy * No concurrent antiviral therapy