MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page of page: 
range. During this hospitalization you are at serious risk of infection and bleeding for which you 
will receive close monitoring. You may require treatment with many antibiotics, and you will 
receive blood and platelet transfusions. If you become critically ill, you will be moved to the 
intensive care unit and may require artificial life supports. On rare occassions, patients will not 
recover their bone marrow function and, therefore, will be at a continued risk of infection and 
bleeding. If this occurs, it is life-threatening and you could die. 
During your hospitalization, approximately 2 teaspoons of blood will be drawn from your 
Hickman catheter daily to study your blood counts and other important blood chemistries. We 
will follow the course of your breast cancer after transplant by CAT scans, x-rays, and bone 
scans. These will be obtained one month after transplant and every 2-3 months, thereafter. If 
your breast cancer does not go away entirely after the bone marrow transplant, or if it returns 
(relapses) after transplant, you will be offered treatment with a standard chemotherapy drug, 
vinblastine, in combination with G-CSF. 
The vinblastine chemotherapy will be given to you as an outpatient through a vein by 
continuous infusion over 5 days. It will be necessary for this chemotherapy to be given through 
a central venous catheter fe.g.. a Hickman) for safety purposes. A small, portable pump that can 
be worn on your belt will be used to administere the vinblastine over the 5 days. You will be 
taught about the care and use of this pump and what to do if it stops working properly. G-CSF 
will be given to you by an under the skin injection beginning on Day 6 daily to help your blood 
counts recover. The G-CSF wili be stopped when your blood counts are in the safe range. You 
or a family member will be taught how to give the injection under the skin so G-CSF can be 
administered at home. The vinblastine will be given to you every 3 to 4 weeks for as long as 
your breat cancer is improving. The side effects of vinblastine include nausea and vomiting, hair 
loss, mouth sores, constipation, numbness, and pain in the jaw, arms and legs. In general, these 
side effects resolve when the drug is stopped In addition, vinblastine can lead to a decrease in 
your blood counts which can increase your risk of infection or bleeding. 
RISKS, TOXICITIES AND INCONVENIENCES 
Each drug in the ICE regimen is toxic and has side effects which could cause any, oall 
omone of the following: nausea and vomiting; sore mouth and throat, diarrhea which may 
become bloody; lowering of the white blood cell count, platelet count and red blood cell count; 
increased risk of infection; loss of body and scalp hair, lung damage with difficulty breathing; 
difficulty walking, muscle weakness, and numbness and tingling of your hands and feet; 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 09-25-0099 
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Recombinant DNA Research, Volume 16 
