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

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00265603

Run by

Atlantic Health System

People needed

16

Starts

2004-10-01

Expected to finish

2009-04-01

Last updated by the study team

2014-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer Stage IIIB. Previously treated with two prior chemotherapy regimens or refused chemotherapy, and able to receive definitive RT. (Patients will not receive chemotherapy during the study). Patients with malignant pleural effusion are not eligible.
• Stage IV with measurable disease in the lung and a medical indication for radiation therapy. (Patients will not receive chemotherapy during the study). These patients must have received and progressed on two prior chemotherapy regimens or have refused chemotherapy.
• Staging by CT scan of chest/abdomen and MRI of brain.
• Willing and able to undergo two (baseline and follow-up) bronchoscopy with BAL and bronchial biopsy for bronchoscopically visible tumor.
• No treatment for lung cancer (chemotherapy, radiation therapy, biomodifiers) for 4 weeks prior to entry.
• Stable or progressive disease.
• No concurrent infection.
• Able to tolerate fluid shifts related to photopheresis (removal of 250 cc of blood and subsequent reinfusion of 250 cc of blood over 1-2 hours).
• ECOG Performance Status < 2.
• At least 18 years of age.
• Adequate bone marrow reserve: hemoglobin > 11 g/dL; platelet count > 100,000 mm3; ANC > 1500/ mL.
• Life expectancy of greater than 3 months.
• Normal peripheral CD8 count.
• Not pregnant or nursing.
• PFTs demonstrating diffusion capacity ≥ 60%, FEV1 ≥ 60%, and vital capacity ≥ 60%.
• Radiotherapy would be offered as appropriate standard therapy outside of a study setting.

You may not qualify if…

• History of or active infection with human immunodeficiency virus (HIV), hepatitis B (by antigenemia), or hepatitis C.
• History of allergic reactions attributed to compounds of similar composition to 8-methoxypsoralen (oxsoralen, trisoralen).
• Significant cardiovascular disease (i.e. NYHA class 3 or higher congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias)
• Pregnant or nursing at time of study entry.
• Participation in an investigational drug trial within 30 days prior to screening.
• Suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the Investigator to be likely to affect their ability to sign the informed consent, or undergo study procedures.
• Presentation with, or a recent history (within 24 hours) of a fever ≥ 38.2°C or symptoms of significant local infection or systemic infection, including urinary tract infections - such patients will be deferred from enrollment at least until 48 hours after illness has resolved.

Where it is running

• Morristown Memorial Hospital — Morristown, New Jersey, United States

Full record on ClinicalTrials.gov

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