informed Consent 
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 type of virus found in mice (called murine retrovirus) has been 
modified to make it inactive so it will not cause human disease. It Is capable of 
carrying a human gene that has been shown in laboratory experiments to 
inactivate or replace defective genes that cause lung cancer. There is also a 
bacterial gene that helps trace these genes. The retrovirus will be injected 
directly 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. 
This experiment is designed as follows: Lung cancer patients whose tumors 
obstruct part of their tracheobronchial trees are eligible to be considered for this 
study. Tumors that are removed during regular bronchoscopic exam will be 
examined to determine whether they contain the specific genetic mutation we 
are attempting to treat. 
Fourteen patients whose tumors have this mutation will be enrolled in this study. 
Tumors must be reducible to a small amount with removal through the 
bronchoscope or laser treatment. If it is not possible to find this mutation in 
specimens from previous 
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