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: Joyce O’Shaughnessv. M.D. 
STUDY TITLEPilot Study of High Dose ICE (Ifosfamide, Carboplatin, Etoposide) 
Chemotherapy and Autologous Bone Marrow Transplant (ABMT) for Treatment of Metastatic 
Breast Cancer 
INTRODUCTION 
We invite you (or your child) 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 youy are otherwise entided. 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 
The currently available therapies for your breast cancer are not curative. The high dose 
chemotherapy in combination with bone marrow transplant that is being offered to you may not 
result in cure of your disease or long term benefit to you. Pre limin ary studies of high-dose 
chemotherapy and bone marrow transplant show that breast cancer may respond to high doses of 
chemotherapy and bone marrow transplant. In general, however, it has not yet been shown that 
patients with metastatic breast cancer are cured by high dose chemotherapy combinations and 
bone marrow transplant. Alternative therapies for your breast cancer include conventional or 
experimental chemotherapy, and possibly treatment with hormones. You may also be treated in 
some cases with surgery and/or radiation therapy. The specific alternatives available for you will 
be discussed with you in detail. 
TRANSPLANT EVALUATION AND PROCEDURES 
In order to determine if you are eligible for this therapy, several tests will have to be done. 
This period of evaluation will take two to three weeks and will be done on an outpatient basis. It 
may include standard blood tests, 24-hour collections of urine, tests of your lung function, heart, 
and hearing, computerized tomography (CAT) scans, nuclear medicine scans of your bones, 
liver/spleen and heart, bone marrow biopsies and possibly, biopsies of suspected ares of tumor if 
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 
