Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Biological: autologous dendritic cell cancer vaccine

• Registration Number: NCT00103116
• Lead Sponsor: Edward Hirschowitz

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed Description

OBJECTIVES:

* Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.

* Determine the potential clinical efficacy of this vaccine in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).

Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-02-07
• Study First Submitted QC: 2005-02-07
• Study First Posted: 2005-02-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2013-11-07
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous dendritic cell cancer vaccine	autologous dendritic cell cancer vaccine	Open label nonrandomized

Primary Outcome Measures

Name	Time	Method
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization	six months post vaccine	Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Alive Five Years Post Vaccine	five years post vaccine	Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine

Trial Locations

Locations (1)

Markey Cancer Center at University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States