Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients with Metastatic Colorectal Cancer to the Liver (Colon)
ID Number 97-0564Principal Investigator(s)
Max W. Sung
Department(s) or Division(s)
Hematology and Medical Oncology
This is a research study to see if the body's immune system can be boosted to fight against cancer cells.
This is done by injecting a genetically altered virus (which is related to the "common cold") into a tumor in the liver. The injection is done with one to three needles which are injected through the skin and placed into a tumor in the liver. An ultrasound examination is done at the same time to track the needles in the liver tumor. No surgery is required; the skin is numbed with a local anesthetic where the needles will pass through to the liver, and the injection takes approximately 15 minutes.
The genetically altered virus does not reproduce itself but can produce a substance called interleukin-12 (IL12). Il12 can enhance the ability of the body's immune system to destroy cancer cells. Animal studies have shown that a single injection of the altered virus into a liver tumor can produce a strong immune response, which led to destruction of tumors and longer survival for some of the treated animals. The virus has been approved by the United States Food and Drug Administration (FDA) only for use in this clinical study, and not for commercial use.
Blood tests and radiology scans will be performed before and after the virus injection to check for side effects and to see if the tumors have decreased in size following the injection.
Recruiting Patients: No