Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer
|Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer||Biological: AdGMCAIX-transduced autologous dendritic cells Biological: therapeutic autologous dendritic cells Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Time Frame: Up to day 57 ]Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
- CAIX-specific immune response [ Time Frame: Up to 3 years ]Measured by ELISpot analysis of T cells from blood and cytokine profiling in T cell cultural supernatants.
- 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 ]
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (autologous dendritic cells)
Patients receive AdGMCAIX-transduced autologous dendritic cells ID on days 1, 15, and 29.
Biological: AdGMCAIX-transduced autologous dendritic cells
Other Names:Biological: therapeutic autologous dendritic cells
Other Names:Other: laboratory biomarker analysis
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) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826877
|United States, California|
|Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Fairooz F. Kabbinavar 888-798-0719 email@example.com|
|Principal Investigator: Fairooz F. Kabbinavar|
|Principal Investigator:||Fairooz Kabbinavar||Jonsson Comprehensive Cancer Center|