Pilot Study of GVAX in Colorectal Cancer Cells
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: GVAX
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage IV; Hepatic Lesions

Summary:

      This study is a Pilot clinical trial. Pilot clinical trials test the safety of an
      investigational combination of drugs. Pilot studies provide information on what effects, both
      good and bad, the Investigational agent might have on your disease. "Investigational" means
      that the intervention is still being studied and that research doctors are trying to find out
      more about it. It also means that the FDA has not approved the treatment for your type of
      cancer.

      The main purposes of this study are to determine:

        -  The amount of vaccine that can be made for your colorectal tumor cells

        -  If the vaccine can be given safely

        -  What the effects of the vaccine are, both good and bad

        -  How the vaccine affects your immune system

        -  Whether this vaccine might have any effect on the return of your cancer in the liver
           after surgical removal

      This study is being done because there are currently no treatments which have demonstrated to
      cure diseae which has progressed, or moved beyond the site of the primary site of disease
      (colon or rectum). These vaccinations will be given after you have completed the standard of
      care treatment as determined by your doctor.

      Laboratory research has made vaccines from cancer cells by inserting genetic material from a
      protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer
      cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The
      vaccine made form these cells has a greater anti-tumor effect than cancer cells without
      GM-CSF. The purpose of this research study is to determine the safety of an investigational
      vaccine that will be made using your own colorectal cancer cells in the manner described
      above.

      This vaccine has been used in several other research studies for treatment for other cancers
      (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies
      suggests that this vaccine may help to reduce the risk of your colorectal cancer returning
      after you have your colorectal cancer surgery.

      Due to these results in melanoma and several other tumors we are encouraged to use this
      vaccine approach in patients with liver metastases from colorectal cancer, after the cancer
      in the liver has been removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented hepatic colorectal cancer metastasis with resectable hepatic
             lesions

          -  At least 4 weeks since last dose of chemotherapy, radiotherapy, immunotherapy,
             systemic glucocorticoid therapy or operation in order to receive vaccine

          -  Fully recovered from hepatic resection

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Uncontrolled active infection

          -  Infection with HIV, Hepatitis B or C

          -  Other current malignancies except in situ cancer or basal/squamous cell carcinoma

          -  Active autoimmune disease

          -  Hepatic metastases involving both branches of the portal vein or all three hepatic
             veins

          -  Peritoneal metastases identified at the time of attempted resection

          -  Greater than 1 month since resection of liver metastasis for vaccine production