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

PHASE1TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Non-Small Cell Lung Cancer
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.

Trial Locations (1)

07962-1956

Morristown Memorial Hospital, Morristown

Sponsors
All Listed Sponsors
lead

Atlantic Health System

OTHER