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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00265603
First received: December 14, 2005
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Procedure: Extracorporeal Photochemotherapy With Transimmunization
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Toxicity/Feasibility Study: Combined Modality Treatment With Transimmunization for Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • 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. [ Time Frame: 1-2 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: October 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Arm
The investigators plan to have approximately 16 persons participate in the study of transimmunization. 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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265603

Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Emil Bisaccia, MD Atlantic Health System
  More Information

No publications provided

Responsible Party: Atlantic Health System
ClinicalTrials.gov Identifier: NCT00265603     History of Changes
Other Study ID Numbers: R04-10-009
Study First Received: December 14, 2005
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014