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Safety Study: Combined Modality Treatment for Non-Small Cell Lung Cancer

NCT00265603 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-01-16

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of using a treatment called transimmunization in addition to standard therapy (radiation) in the treatment of lung cancer. Transimmunization is a treatment of the blood designed to boost the immune response against lung cancer. Transimmunization uses a device called a UVAR-XTS instrument, to remove a portion of blood, part of which is returned, and part of which is incubated overnight before being returned to the bloodstream the next day.

Conditions

Interventions

PROCEDURE

Extracorporeal Photochemotherapy With Transimmunization

The photopheresis apparatus and procedure will be identical to that currently used. Patients will receive intravenous 8-MOP (UVADEX®) directly into the photopheresis apparatus, to yield a concentration of 50-200 ng/ml of drug. The blood will be leukapheresed to obtain a buffy coat and will then be passed through the contiguous closed circuit ultraviolet A exposure device, delivering the desired 1-2 joules/cm2 of ultraviolet A energy. In this manner 2-4 molecules of 8-MOP will be induced to bind covalently to thymines of the leukocyte DNA. At that point, the single variation from the standard treatment will be initiated. Instead of returning the patient's cells and the saline to the patient, the bag will be detached from the apparatus. KLH (depyrogenated, endotoxin-free; Calbiochem-Novabiochem Corp., San Diego, CA) will be added at a concentration of 10 g/ml to the DC-rich leukocyte culture prior to overnight culture.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Emil Bisaccia, MD · Atlantic Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00265603 on ClinicalTrials.gov