4 . 
prior to a dminis tration. 
Each patient will receive daily, 250 /ig/m 2 of rhGM-CSF via IV infusion 
over a minimum of 2 hours. The necessary amount of reconstituted rhGM- 
CSF should be diluted in sufficient sterile isotonic saline containing 0.1% 
human serum albumin (HSA) for the 2 hour IV infusion. 
10. Procedure of Peripheral Blood Nucleated Cell Collection 
Before receiving the 8th dose of rhIL3, approximately 20 hours after the 7th dose of 
rhIL3 the first of four consecutive peripheral blood nucleated cell collections will begin. 
Collections will take place in the FHCRC Pheresis Unit and use the Cobe 2997 machine. A 
short double lumen catheter is necessary for peripheral blood collections. Collections will be 
performed for 4 hours on 4 successive days. Peripheral blood cells will be cryopreserved by Dr. 
Petersen’s laboratory. 
< 
11. Procedure of CP 34 and CD33 Cell Surface Antigen Expression Analysis 
Fifteen daily samples of blood (10 cc in a heparinized syringe) will be drawn for analysis 
of CD34 antigen expression. The first sample will be drawn just prior to the first dose of rhIL3. 
During the period of peripheral blood cell harvesting samples will be drawn just prior to each 
collection. Once collections of peripheral blood cells are completed, samples will be drawn for 
the following four days. Analysis will be done at the FHCRC with the FACS by Bill 
Bensinger’s laboratory. 
Variables to be evaluated 
A. Primary Variables 
1. Toxicity related to rhIL3. 
2. Percent of cells expressing CD34 antigen. 
3. Number of days the ANC is less than 100/mm 3 . 
4. Number of days of platelet transfusion dependence. 
B. Secondary Variables 
1. Time to the absolute granulocyte number to exceed £500 cells/mm 3 on two 
consecutive days by daily CBC and WBC differential counts. 
2. Frequency and duration of infections. An infection is defined as follows: 
a. Bacteremia: One or more positive blood culture(s) associated with 
fever as the only sign of infection, or more than one positive blood 
culture with the same organism, regardless of signs of infection. 
b. Septicemia: One or more positive blood culture(s) for any organism 
associated with either hypotension or documented local infection 
caused by the same organism recovered from the blood. 
c. Local infection: Microbiological isolation of organisms from a site 
• associated with signs or symptoms of infection. Organisms 
recovered were capable of causing the dim cal findings. "Qinical" 
local infection denoted signs and symptoms of an infected site in the 
absence of microbiological confirmation. Oral cavity, upper 
respiratory, and herpes simplex infections were not recorded. 
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Recombinant DNA Research, Volume 16 
