Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
- 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
- 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
- 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
- If enough vaccine cannot be made for the participant to receive 3 doses, the
participant may receive only 2 doses of the study vaccine.
- Approximately 3 to 4 tablespoons of blood will be collected at certain times for
testing the immune system and to determine if the study vaccine has increased the
immune response against the tumor cells. Weekly visits for physical exam, assessment
of adverse events and safety labs will be conducted.
- Regular blood draws will be done for at least 6 months following the completion of the
study to follow safety labs and to monitor the immune response. Monthly physical exams
will be performed following the last injection of the study vaccine. At one month,
three months, and six months following the date the participant received the last study
vaccine, they will have a CT scan to see if the study vaccine has affected their
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
David Avigan, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
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