CT1030: : A phase I/II, open-label study (with a sequential dose escalation stage followed by an expansion of a selected dose cohort), to evaluate the safety and anti-tumor effects of NV1020, administered repeatedly via hepatic artery infusion prior to second-line chemotherapy, in patients with colorectal adenocarcinoma metastatic to the liver. Version 5, 28 August 2006

Why is this study being done? 
This is a research study of a new investigational product called NV1020 (referred to as the study drug) that is being tested as a possible treatment for patients with colorectal cancer that has spread to the liver. The study drug is a weakened version of the herpes simplex virus (HSV1). HSV1 may causes cold sores and rarely causes severe brain infection. NV1020 has been altered so that we hope it cannot grow and infect normal cells. We also hope that the study drug will not cause cold sores. Prior research shows that the study drug may be able to infect tumor cells and destroy them. Prior research also suggests that giving the study drug along with chemotherapy may enhance the effects of chemotherapy treatment. We would like to put the NV1020 directly into enrolled subject’s liver to see whether this can be done without side effects and if this procedure might work to make the tumor cells go away. The study drug is at this time in clinical development and has not been approved by the Food and Drug Administration.

Who is Eligible to Participate in this Study? 
Those patients who have colon and/or rectal cancer that has spread to the liver which has failed to respond to chemotherapy. While in this study, patients will be given a standard chemotherapy. Before starting this chemotherapy, we wish to find out if giving a new virus treatment is of any benefit to patients and treatment of colon or rectal cancer.

Minimum Age: 18
Maximum Age: 75

What is Involved With this Study? 
Patients who qualify for this study will get 4 weekly infusions with the study drug. This may be changed to every other week if blood test results are not thought to be within safe limits and the study doctor thinks this is best. All study drug doses will be given into a main artery that supplies blood to the liver. This will be done through a small tube pushed into the liver to inject the study drug. The tube is inserted through a blood vessel in the groin area. This is done in a special x-ray room.

After we inject each dose patients will be watched in case there are side effects. Once the study doctor feels the patient is stable, he/she will be moved to a standard hospital bed in the Clinical Research Center for further observation. The patient will likely remain in the research center for 1 to 3 days after the first time the study drug has been given.

One to 2 weeks after the last dose of the study drug, the patient will start the first of 2 cycles of standard chemotherapy. Each cycle of chemotherapy may last between 4 and 6 weeks, depending on what the study doctor chooses for you. This portion of the study is considered standard of care.

After the 2 cycles of chemotherapy have been done, patients will return to the clinic every 3 months for 3 more visits. Each time, there will be many exams and tests, which include a physical exam, blood tests and scans.

After the study has finished (about 12 months) the patient will be called by phone at least every 3 months for the rest of his/her life, to check on health status, and to check for signs or symptoms of herpes virus.