NCT00098917

Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	autologous tumor cell vaccine
DRUG	therapeutic autologous dendritic cells
PROCEDURE	adjuvant therapy
PROCEDURE	biological therapy
PROCEDURE	conventional surgery
PROCEDURE	surgery
PROCEDURE	tumor cell derivative vaccine
PROCEDURE	vaccine therapy

Timeline

• Start date: 2005-02-01
• First posted: 2004-12-09
• Last updated: 2008-01-28

Locations

1 site across 1 country: United States