Trial Information

Summary: 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

This is an NCI-supported and FDA-approved clinical translational trial to evaluate tumor immunization as a therapeutic modality for patients with metastatic colorectal cancer. The immunization is performed by placing one to three needles into a metastatic tumor in the liver. An ultrasound examination of the liver is performed at the same time to track the needles in the liver. An adenovirus (ADV-hIL12) which has been genetically altered so that it cannot reproduce itself and produce an infection but can express an immune-enhancing protein called interleukin-12 (IL12). No surgery is required for this procedure, which is performed under local anesthesia. In animal studies a single intratumoral injection of the altered adenovirus induced a strong anti-tumor immune response which led to tumor regression at metastatic sites and long-term survival.
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Patient Inclusion/Exclusion Criteria:

Men or women with metastatic colorectal adenocarcinoma:
- At least one metastatic tumor must be in the liver and measures at least 2 cm in diameter.
- Patients may have additional metastatic tumors in or outside the liver.
- Patients may have had prior treatment for colorectal cancer.

More than 40% of liver involved with tumor.
Severe liver disease with poor liver function.
No active infection, including HIV.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.