A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
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.
Primary Purpose: Treatment
Barbara J. Gitlitz, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|