Phase I Trial Of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously With Concurrent Cisplatin and Radiotherapy in Patients With Locoregionally Advanced Head and Neck Carcinoma

Inclusion Criteria:

- Confirmed diagnosis of histologically or cytologically documented Stage III to IVB
primary, non-metastatic head and neck cancer for newly diagnosed patients with no
prior disease-related treatment (e.g., chemotherapy, radiation treatment, surgery,
etc.).

- American Joint Committee on Cancer (AJCC) Stage III-IVB disease (2010 manual, 7th
edition), based on standard diagnostic workup.

- 18 years or older.

- ECOG performance status of ≤ 2.

- Laboratory data obtained within 14 days prior to Treatment Day 1, with adequate
hepatic and renal function defined as follows:

- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;

- Platelets ≥ 100,000 cells/mm3;

- Hemoglobin ≥ 8.0 g/dL;

- Bilirubin ≤ 1.5 mg/dL;

- AST or ALT ≤ 2× upper limit of normal (ULN);

- Serum creatinine ≤ 1.5 mg/dL;

- Creatinine clearance (CC) ≥ 50 mL/min.

- Pulse oximetry reading of 92% or higher at rest on room air.

- Signed informed consent

- Women of childbearing potential must have a negative serum pregnancy test and agree
to practice effective birth control during treatment phase and up to 60 days after
the last virus application.

- Male patients must agree to practice effective birth control during the study and for
60 days following administration of last treatment of virus.

Exclusion Criteria:

- Clinical, radiographic, or pathologic evidence of distant metastatic disease.

- Patients with fever, active immunosuppressive systemic infection or a suppressed
immune system, including AIDS or HIV positivity and known hepatitis infections (HCV
or HBC. Eligible patients must have an HIV test conducted within 4 weeks prior to
study enrollment with a negative test result.

- Any form of prior anti-cancer treatment.

- Disease-related surgery, excluding biopsy.

- Patients with CNS (Central Nervous System) tumors.

- Any other open wounds.

- Concurrent small pox vaccination for 4 weeks before study therapy and during study
treatment.

- Patients on immunosuppressive therapy or with immune system disorders, including
autoimmune diseases.

- Prior splenectomy.

- Previous organ transplantation.

- Patients with clinically significant dermatological disorders, as judged by the
clinical investigator (e.g., eczema or psoriasis), any skin lesions or ulcers, any
history of atopic dermatitis, or any history of Darier's disease (Keratosis
Follicularis).

- Clinically significant cardiac disease (New York Heart Association: Class III or IV).

- Dementia or altered mental status that would prohibit informed consent.

- Known allergy to ovalbumin or egg products.

- Prior gene therapy treatments or prior therapy with cytolytic virus of any type.