Clinical Trial: Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

Brief Summary: The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Detailed Summary:

  • Patients are being asked to participate if they have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in their body) as a standard treatment for kidney cancer or they have tumor lesions that are accessible and are being removed to treat or diagnose their cancer.
  • Participants enrolled in this study will be assigned to receive a particular dose of the dendritic cell/tumor fusion vaccine cells. The dose will be determined by when they are enrolled in the study. There are two cohorts to this study. The first cohort will be given the vaccine alone. If the vaccine is well tolerated then we will proceed to the second cohort. The second cohort will receive GM-CSF in addition to the vaccine.
  • Tumor cells will be collected to make the study vaccine. Based on the location of the cancer, a decision will be made as to the best approach to obtain these cells.
  • Participants will undergo a procedure known as leukapheresis in order to obtain their dendritic cells. Prior to this procedure they will receive 1 to 2 injection of GM-CSF to help increase their white blood cell count.
  • If sufficient numbers of cells are obtained, tumor cells and dendritic cells will be fused (mixed) together in the laboratory and divided into the appropriate doses for administration.
  • The treatment will consist of 3 vaccinations of fused cells given by an injection under your skin at 3-week intervals. The first six participants will receive only the study vaccine. The remaining participants will receive the study vaccine combined with GM-CSF.
  • If enough vaccine cannot be made for the participant to receive 3 doses, the participant may receive only 2 d
    Sponsor: Beth Israel Deaconess Medical Center

    Current Primary Outcome: Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF [ Time Frame: 5 years ]

    Original Primary Outcome: To Assess the Toxicity Associated With and to Investigate the Clinical Impact of Vaccination With Mature DC/Tumor Fusion and GM-CSF of This Patient Population.

    Current Secondary Outcome:

    • To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF [ Time Frame: 5 years ]
    • to Correlate Immunologic Response Following Vaccination. [ Time Frame: 5 years ]


    Original Secondary Outcome:

    • To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF
    • to Correlate Immunologic Response Following Vaccination.


    Information By: Dana-Farber Cancer Institute

    Dates:
    Date Received: April 10, 2007
    Date Started: October 2004
    Date Completion: December 2016
    Last Updated: September 22, 2016
    Last Verified: September 2016