MEDICAL RECORD 
' - - 1 - 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
* Adult Patient or * * Parent, for Minor Patient 
INSTITUTE: NATIONAL CANCER INSTITUTE 
STUDY NUMBER: PRINCIPAL INVESTIGATOR: Joyce O’Shaughnessy, MX). 
STUDY TITLE:Retroviral-Mediated Gene Transfer of Bone Marrow Cells During 
Autologous Bone Marrow Transplantation for Metastatic Breast Cancer 
INTRODUCTION 
We invite you to take part in a research study at the National Institutes of Health. It is 
important that you read and understand several general principles that apply to all that take part 
in our studies: (a) taking part in the study is entirely voluntary; (b) personal benefit will not 
result from taking part in this study, but knowledge may be gained that will benefit others; (c) 
you may withdraw from the study at any time without penalty or loss of any benefits to which 
you are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and 
other pertinent information about the study are discussed below. You are urged to discuss any 
questions you may have about this study with the staff members who explain it to you. 
NATURE OF STUDY 
Autologous bone marrow transplantation is a treatment with potential benefit for metastatic 
breast cancer. Autologous bone marrow transplantation and its risks have been explained to you 
in a separate Informed Consent document and you have agreed to be enrolled in our 
transplantation protocol. Youare being asked to take part in a research study of 
“retroviral-mediated gene transfer” of bone marrow cells used during autologous bone marrow 
transplantation. 
The intent of this protocol is to treat you with high dose chemotherapy and to then give you 
back your bone marrow, part of which has been “marked” with a special gene described below. 
The goal of this study is to determine whether it is possible to put a new gene into bone marrow 
cells that will stay in your body for several months or more. It is not yet known whether it is 
possible to successfully place new genes into patients’ bone marrow cells and to have the genes 
stay in the bone marrow cells over several months. If this could be accomplished, it would 
represent an important potential advance in the treatment of many diseases. We may also learn 
important information that could improve the safety and usefulness of autologous transplantation 
in breast cancer. 
You are being asked to take part in a research study that will try and accomplish the 
placement of a bacterial gene called neo into your bone marrow cells. Part of the study 
D 
involves testing bone marrow cells periodically to see whether the neo gene is in your bone 
marrow cells and how long the gene stays there. The new technology involved in this research 
protocol is called “retroviral-mediated gene transfer.” It will be used to put a gene ('neo ) mto 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
• Adult Patient or ‘Parent, for Minor Patient 
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Recombinant DNA Research, Volume 16 
