This phase I trial studies the side effects and best dose of autologous dendritic cells in treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of dendritic cell (DC)-AdGM carbonic anhydrase IX (CAIX) administered by intradermal injections at study doses and schedule. SECONDARY OBJECTIVES: I. To evaluate clinical antitumor effects following study treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Parameters include objective response (complete response \[CR\], partial response \[PR\]), duration of response in patients with objective response, and time to disease progression. II. To evaluate immune responses to DC-AdGMCAIX vaccination by enzyme-linked immunospot (ELISpot) for numeric determination of CAIX specific T cells in blood. III. To evaluate immune responses to DC-AdGMCAIX vaccination by cytokine profiling of T cell culture supernatants for characterization of the immune response in subjects with demonstrated immune activation may be performed. IV. To evaluate immune responses to DC-AdGMCAIX vaccination by anti-sargramostim (GM-CSF) antibody response. V. To evaluate tumor biopsies for immune cell infiltrates. OUTLINE: This is a dose-escalation study. Patients receive AdGMCAIX-transduced autologous dendritic cells intradermally (ID) on days 1, 15, and 29. After completion of study treatment, patients are followed up every 2-3 months for at least 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Incidence of adverse events including all grade 3 and grade 4 adverse events regardless of causality, treatment-related adverse events, dose limiting toxicities (DLT), and adverse events leading to discontinuation of study treatment
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Time frame: Up to day 57
CAIX-specific immune response
Measured by ELISpot analysis of T cells from blood and cytokine profiling in T cell cultural supernatants.
Time frame: Up to 3 years
Objective response (CR, PR) according to RECIST guideline version 1.1
Time frame: Up to 3 years
Duration of progression-free survival
Time frame: Up to 3 years
Clinical benefit rate (CR, PR, and SD) greater than or equal to 12 weeks
Time frame: Up to 3 years
Disease response (CR, PR, stable disease [SD], and progressive disease [PD]) according to RECIST guideline version 1
Time frame: Up to 3 years
Duration of response according to RECIST guideline version 1
Time frame: Up to 3 years
Time to disease progression
Time frame: Up to 3 years
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