MEDICAL 
RECORD 
STUDY NUMBER: 
CONTINUATION SHEET for either: 
NIH 2514-1 , Consent to Participate in A Clinical Research Study 
NIH 25 1 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
CONTINUATION: page of page: 
confusion, difficulty thinking and coma; damage to the liver, heart, and kidneys; bladder 
irritation with bleeding; skin damage due to local infiltration of drug; genetic risk to a baby if 
you become pregnant; a new tumor in another organ; irregular menstrual periods or stopping of 
menses and sterility. Because bone marrow transplant uses very high and toxic doses of 
chemotherapy, patients may die from a side effect of any of these drugs or from bleeding or 
infection during the period of low blood counts. In studies from other medical centers, up to 
15% of patients have died from bone marrow transplant. Additionally, permanent and serious 
damage may occur to vital organs, and there is the risk of an uncommon or previously unknown 
side effect occurring from the chemotherapy. Because of these toxicides we may need to 
transfer you to the intensive care unit for medical treatment if you become seriously ill. Should 
this occur, your physicians will discuss with you your designating a Durable Power of Attorney 
for Health Care, i.e., a person who can speak for you in the event you are too ill to do so for 
yourself. High dose therapy with ICE chemotherapy is relatively new (approximately 50 patients 
have been trated at NCI with ICE) and there is also a risk of more serious or unknown side 
effects due to the combination of these drugs in high doses. In very high doses, ifosfamide may 
cause sleepiness, confusion, and damage to your kidneys and bladder with blood in your urine. 
In high doses, CBDCA may cause loss of hearing and damage to your nerves, confusion, liver 
and kidney damage. You will also receive the drug MESNA which protects your urinary bladder 
from damage caused by ifosfamide. MESNA may cause nausea, vomiting and diarrhea. 
G-CSF can cause the following side effects: bone pain, muscle aches, headache, elevated 
liver enzymes in the blood, elevated uric acid (may lead to kidney stones), enlarged spleen, and 
worsening of pre-exisiting inflammatory diseases such as psoriasis or vasculities. Allergic 
reactions including chest pain and a decrease in blood pressue have been seen rarely with the 
first injection. 
COMMUNICATIONS 
The NCI physicians involved in your care are available to answer all of your questions 
concerning this protocol. The principal investigator is Dr. Joyce O’Shaughnessy and can be 
reached at (301)496-4916 to answer your questions. The NIH patients’ rights representative, 
Betty Schwering (496-2626) will be available to answer questions you maybe have concerning 
your involvement in this study or your rights as a research subject. A copy of this informed 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-2514-2 (10-84) P.A.: 
09-25-0099 
Recombinant DNA Research, Volume 16 
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