Clinical Trial: Vaccine Therapy after Surgery

Can the body develop an immune response that will destroy cancer cells in the body and prevent cancer from returning after surgery to remove metastatic tumors?  If it can, what’s the best way to do that?

Researchers are studying vaccines and immune response in patients whose colorectal cancer has spread beyond their original cancer to their liver or lungs.  They’re looking for patients who have completed surgery for a  clinical trial of PANVAC-VF.

In order to be eligible, patients must have:

  • had surgery to completely remove metastatic tumors in their liver or lungs.
  • have no sign of remaining cancer.
  • received chemotherapy for at least two months before or after their surgery.

Patients will randomly receive vaccine treatment in one of two ways:

  • Autologus DC: White blood cells will be removed from the patient’s own blood and the dendritic cells treated in the lab with the two vaccines being used for the trial (PANVAC-V and PANVAC-F). On the first day of trial treatment, patients will receive their own dendritic cells, which have been prepared with PANVAC-V, by an injection under the skin.  On the second day, their dendritic cells treated with PANVAC-F will be injected.  The second-day treatment will be repeated 1, 7, and 11 weeks later.
  • Sargramostin: Patients will not have their own dendritic cells injected.  Instead they will receive PANVAC-V on the first day of treatment and PANVAC-F at the beginning of the 4th, 8th, and 12 weeks. They will also receive sargramostim (GM-CSF) for three days with each vaccine treatment.

PANVAC-V is vaccinia-CEA-MUC-1-TRICOM vaccine.  PANVAC-F is fowlpox-CEA-MUC-1-TRICOM vaccine.

The primary goal of the study is to find out how many patients are alive and cancer-free two years after treatment.  Immune response will also be measured.

The study is being conducted at cancer centers in Washington DC, Houston, Durham and Winston-Salem, NC, Portland OR, Tampa, and Charleston, SC.  Contact information for each center is available on the NCI Clinical Trials site.

For more information, you can contact the lead organization:

  • Michael Moore, MD
  • 919–681–3480
  • Duke Comprehensive Cancer Center

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