A Phase I Clinical Trial of Mature Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
- Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with
irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung
cancer undergoing resection.
- Determine the safety and tolerability of this vaccine in these patients.
- Determine the feasibility of this vaccine in these patients.
- Determine vaccine-specific and antitumor immunity in patients treated with this
OUTLINE: This is a dose-escalation study.
Patients undergo leukaphersis to isolate peripheral blood mononuclear cells (PBMC). PBMC are
expanded ex vivo to generate monocyte-derived dendritic cells (DC). Autologous tumor cells
are harvested and purified at the time of surgical resection. DC are then loaded with
irradiated autologous tumor cells.
Within 4-8 weeks after surgical resection, patients receive autologous DC loaded with
irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the
absence of unacceptable toxicity.
Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose
(MTD) is determined. If 2 of 9 patients in the first cohort experience dose-limiting
toxicity, that dose level is considered the MTD.
Patients are followed at approximately 1 and 4 months, and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 18
Primary Purpose: Treatment
Michael D. Roth, MD
Jonsson Comprehensive Cancer Center
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|