THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
Protocol Title: "Clinical Protocol for Modification of Oncogene and Tumor 
Suppressor Gene Expression in Non-Small Cell Lung Cancer 
(NSCLC)" 
1 . 
Participant’s Name i.D. Number 
You have the right to know about the procedures that are to be used in your participation in 
clinical research so as to afford you an opportunity to make the decision whether or not to 
undergo the procedure after knowing the risks and hazards involved. This disclosure is not 
meant to frighten or alarm you; it is simply an effort to make you better informed so that you 
may give or withhold your consent to participate in clinical research. This informed consent 
does not supersede other consents you may have signed. 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF THE STUDY: This is a clinical research study to evaluate a new 
therapy. A retrovirus that is inactivated and contains a gene that will inactivate or 
replace defective cancer causing genes in lung cancer will be directly injected into 
lung cancer cells that are growing and obstructing the airway to the lung. 
3. DESCRIPTION OF RESEARCH: It has been recognized that cancer is associated with 
abnormalities in certain genes (oncogenes) which can become mutated or lost during 
the process of cancer development. This study is an attempt to restore a pattern of 
normal behavior to the cancer cell by correcting one of these gene abnormalities. 
The experimental protocol is as follows: A total of 14 patients who have known tumors 
within their airway will be examined. These patients are scheduled to have 
bronchoscopic exams as part of their evaluation either under local anesthesia or 
general anaesthesia. The surgeon performs an examination using a regular white 
light source to illuminate the tracheobronchial tree. If a tumor is found that is 
obstructing a portion of the tracheobronchial tree, that patient will be considered 
eligible for the study. Patients will not be eligible for radiation therapy or surgery. It 
must also be possible to reduce the number of tumor cells to a small amount with 
removal through the bronchoscope or laser treatment. The tumor must have a 
specific gene mutation in it. It may be possible to find this mutation in specimens from 
previous biopsies. However, it these are not available new biopsies must be 
performed. If the new biopsy material does not show the mutation, the patient cannot 
participate in the study. The residual tumor will be injected daily for 5 consecutive 
days with a retrovirus containing a gene that can correct an abnormality detected in 
Recombinant DNA Research, Volume 16 
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