Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.
Drug: autologous tumor cell vaccine
Drug: therapeutic autologous dendritic cells
Procedure: adjuvant therapy
Procedure: biological therapy
Procedure: conventional surgery
Procedure: tumor cell derivative vaccine
Procedure: vaccine therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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)|
|Study Start Date:||February 2005|
- 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 vaccine.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098917
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Michael D. Roth, MD||Jonsson Comprehensive Cancer Center|