A Phase I, Open Label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With Ad-GMCAIX in Patients With Metastatic Renal Cell Carcinoma
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.
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)
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
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Up to day 57
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|