CLINICAL TRIAL: ACTIVE IMMUNOTHERAPY AFTER RESECTION OF HEPATIC METASTASES OF CO

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine if one of two immunization therapies is the most effective in keeping the cancer from recurring following surgery and chemotherapy. This study is being sponsored by a grant from the National Cancer Institute (NCI). Therion Biologics is supplying some of the investigational drugs (PANVAC-F and PANVAC-V) used in this study. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) for use in humans. The two ways to stimulate the immune system are called 1) PANVAC-V followed by PANVAC-F along with GM-CSF. This involves being injected with two different kinds of viruses that can tell the immune system to attack cancer cells that contain the protein CEA found in most colon cancers. GM-CSF is an immune stimulating molecule. 2) Dendritic cells plus PANVAC-V followed by dendritic cells plus PANVAC-F. This involves being injected with special immune stimulating cells normally found in the body called dendritic cells, mixed with the two kinds of viruses. In this study, subjects will be randomly assigned to receive either the PANVAC-V followed by PANVAC-F along with GM-CSF or dendritic cells plus PANVAC-V followed by dendritic cells plus PANVAC-F. Control subjects not receiving either treatment will have their own consent, allowing the PI to collect information on their treatments and follow-ups. This control group will serve as a comparison to those people who received vaccine therapy as a way to determine if there are any differences in cancer recurrence.