Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx
About this trial
This is an interventional treatment trial for Recurrent Salivary Gland Cancer
Eligibility Criteria
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
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (PV701)
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.