Kidney Cancer Clinical Trial
Official title:
A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who
have advanced kidney cancer.
OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in
patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this
regimen in this patient population. III. Evaluate the clinical response to this regimen in
this patient population.
OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to harvest
primary tumor for vaccine preparation. Patients without primary tumor undergo surgical
resection of the accessible metastatic site for vaccine preparation. Patients are assigned to
1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor
lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with multiantigen liposome
loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients receive vaccinations
as in arm I, except DC are pulsed with tumor cells. Arm III: Patients receive vaccination
with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by vaccination with
multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients receive
vaccinations as in arm III, except DC are treated as in arm II. Patients are followed on days
28, 42, 70, and 112.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
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