NCT01826877

Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AdGMCAIX-transduced autologous dendritic cells	Given ID
BIOLOGICAL	therapeutic autologous dendritic cells	Given ID
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-01-14
• Primary completion: 2018-07-03
• Completion: 2021-05-27
• First posted: 2013-04-09
• Last updated: 2021-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study