Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

Inclusion Criteria: Each patient MUST:

• have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamouscell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patients with NPC without distal metastasis(es) or with undifferentiated NPC are noteligible).

• have at least one lesion that is measurable by computed tomography or magneticresonance imaging (Lesions persisting in previously treated radiation fields areconsidered not evaluable for response except if representing a relapse in a mucosal ornodal lesion that previously demonstrated a complete response. Any new lesion withinthe previous radiation fields is acceptable for determination of response and/orprogression).

• have completed first line chemotherapy for R/M SCCHN which progressed on or within 190days following the completion of platinum or platinum-based chemotherapy.

• have no continuing acute toxic effects (except alopecia) of any prior radiotherapy,chemotherapy, or surgical procedures. Any surgery involving the SCC for which thepatient is being treated (except biopsies) must have occurred at least 28 days priorto study enrollment.

• have received no chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days.

• have ECOG Performance Score of ≤ 2.

• have life expectancy of at least 3 months.

• absolute neutrophil count (ANC)≥ 1.5 x 10^9/L ; platelets ≥100 x 10^9/L]; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN.

• negative pregnancy test for females with childbearing potential.

• Be wiling and able to comply with scheduled visits, the treatment plan, and laboratorytests.

Exclusion Criteria: No patient may:

• receive concurrent therapy with any other investigational anticancer agent while onstudy.

• have been treated with a taxane for SCCHN.

• have current -- or with a history of -- brain metastases because of their poorprognosis and because of the frequent development of progressive neurologicdysfunction that would confound the evaluation of neurologic and other adverse events.

• be on chronic immunosuppressive therapy or have known HIV infection or activehepatitis B or C.

• be a pregnant or breast-feeding woman. Female patients of childbearing potential mustagree to use effective contraception, be surgically sterile, or be postmenopausal.Male patients must agree to use effective contraception or be surgically sterile.Barrier methods are a recommended form of contraception.

• have clinically significant cardiac disease (New York Heart Association, Class III orIV) including, but not limited to, pre-existing arrhythmia, uncontrolled anginapectoris, or myocardial infarction within 1 year prior to study entry.

• have dementia or any altered mental status that would prohibit informed consent.

• have any other acute, or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation or studydrug administration or may interfere with the interpretation of study results and, inthe judgment of the Principal Investigator, would make the patient inappropriate forthis study.