Patient Selection

All of the patients who qualified for this study had tumors of the head or neck which had previously failed to respond to either chemo or radiotherapy.

Tumor Selection

Tumors were selected for injection with ONYX-015 primarily by size, with larger tumors preferred over smaller tumors. Some of the selected tumors were left untreated, and served as controls for the experimental clinical trial.

ONYX-015 Mechanism

ONYX-015 is a virus with a deletion of the E1B Gene. In an unaltered virus, the E1B Gene allows the virus to replicate in normal healthy cells by counteracting P53, a protein that controls cell division. P53 deficiency in a cell often leads to cancer, which is why a virus that replicates exclusively in P53 deficient cells might be useful-it should selectively kill tumor cells.  The cell line used to produce ONYX-015 is a human embryonic kidney cell line.

Injection

     Once grown, the virus was loaded into a syringe and injected into multiple sites within the tumor over a period of 5 days. In this study, about 1/3 the overall volume of the tumor was injected with ONYX-015at each session. In addition to the virus, participants in the study were given chemotherapy.

Follow up

During the treatment period, the tumors were measured every 3 weeks by physical examination, and every 6 weeks by MRI. After completion of active treatment, tumors were inspected every 8 weeks.