Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

Inclusion Criteria:

* Histologically-confirmed, advanced/metastatic solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
* At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter \> 1 cm)
* At least one tumor mass amenable to biopsy and/or FNA
* Expected survival for approximately 16 weeks or longer
* Karnofsky Performance Score (KPS) ≥ 70
* Age ≥18 years
* WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
* ANC ≥ 1,500 cells/mm3
* Hemoglobin ≥ 10 g/dL
* Platelet count ≥ 100,000 plts/mm3
* Total bilirubin ≤ 1.5 x ULN
* AST, ALT ≤ 2.5 x ULN
* Serum chemistries within normal limits (WNL) or Grade 1 - If patients are diabetic or have a screening random glucose \> 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
* Acceptable coagulation status: INR ≤ (ULN + 10%)
* CD4 count ≥ 500/mm3

Exclusion Criteria:

* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
* Known myeloproliferative disorders requiring systemic therapy
* History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
* Tumor(s) invading a major vascular structure (e.g. carotid artery)
* Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the upper airway or affecting biliary tract drainage, etc.)
* Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
* Severe or unstable cardiac disease
* Current, known CNS malignancy (history of completely resected or irradiated brain metastases allowed)
* Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
* Use of anti-viral, anti-platelet, or anti-coagulation medication \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\]
* Pulse oximetry O2 saturation \<90% at rest
* Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination

Household contact exclusions:

* Women who are pregnant or nursing an infant
* Children \< 5 years old
* History of exfoliative skin condition (e.g. eczema) that at some stage has required systemic therapy
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)