MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
* Adult Patient or * Parent, for Minor Patient 
INSTITUTE: NATIONAL CANCER INSTITUTE 
STUDY NUMBER: PRINCIPAL INVESTIGATOR: Jovce O’ShaughnesSV. M.D. 
STUDY TiTLE: Retroviral Mediated Transfer of the Human Multidrug Resistance Gene 
(MPR-1) into Hematopoietic Stem Cells during Autologous Transplantation after 
Intensive Chemotherapy 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 may 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, the return of one’s own bone marrow 
following high dose chemotherapy, 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. You are now also being asked to take part 
in a research study in which a portion of the bone marrow and circulating blood cells 
will be marked with a special gene before the cells are put back into you. 
Genes are the hereditary material present in all body cells. They control the 
proteins made in the cell, which in turn determine how the cell functions. When 
special genes are inserted into cells, the cells are referred to as “marked" since they 
can be distinguished in the laboratory from identical cells without the insertion. Putting 
a gene into yourells is an experimental approach we are studying to try and improve 
future therapies. 
In this protocol we will treat you with high dose chemotherapy and then return 
your bone marrow and circulating blood cells, some of which have been “marked” with 
the special gene described below. The goal is to determine whether it is possible to 
put a new gene into bone marrow cells, genes that will stay in your body for several 
months or more. If this could be accomplished, it would represent an important 
potential advance in the treatment of many diseases. We may also gain information 
that could improve the safety and usefulness of autologous transplantation in breast 
cancer. We will also study whether the added gene will increase in numbers after 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY <H 
•Ad ul t Pati e nt o r • • Pa re nt , fo r Mi no r -Patient 
Recombinant DNA Research, Volume 18 
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