PURPOSE 
The purpose of this study is to evaluate complications from the combination of rhIL-3, rhGM-CSF, and 
infusion of peripheral blood cells that are given in an attempt to shorten time to engraftment, to reduce 
infection and to allow earlier hospital discharge following autologous transplantation. This is a dose 
escalation (different and increasing drug doses) trial in which up to 20 patients will participate. 
\ 
PROCEDURES 
The first group of patients enrolled on this study (approximately 6) will have marrow harvested and 
stored. Then peripheral blood will be collected on four consecutive days and frozen according to 
i Protocol #506. The collected blood will be reinfused with the autologous marrow after a standard 
conditioning regimen. RhGM-CSF will be administered each day from day 0-20. 
After six patients have been entered on the study, the subsequent patients will receive 10 daily doses of 
rhIL-3 administered as a two hour infusion in the Outpatient Department to stimulate peripheral cells. 
After the 7th dose of rhIL-3, the peripheral blood will be collected by pheresis on four consecutive days 
and frozen according to Protocol #506. At day 0, the rhIL-3 stimulated peripheral blood and 
autologous marrow will infused. RhGM-CSF will be administered each day from day 0-20. 
Daily blood samples (2 teaspoons) will be collected to monitor progress of patients in both groups. You 
will be closely watched for signs of infection. If severe life-threatening problems relating to rhIL-3 
occur, then this drug will be stopped by the investigator. 
RISKS 
Human and animal data suggest that rhIL-3 is well tolerated. However, in preliminary unpublished 
human studies, rhIL-3 appears to cause short-term muscle and bone pains, low grade fever and 
headaches in 10-20% of patients during the time of treatment Pain medication will be available to 
treat these side effects if necessary. In animal trials high doses of rhIL-3 have caused rashes and liver 
toxicity, but in humans this has not been observed. 
• RhGM-CSF appears to cause transient muscle and bone pains during the time of treatment in 25% of 
patients. Occasional headaches, episodes of nausea and low grade fever have also been observed in 
patients receiving rhGM-CSF. 
RhGM-CSF has been shown to stimulate leukemic cell growth in rare patients who have greater than 
15% leukemic cells in the bone marrow when they receive rhGM-CSF. RhIL-3 has been shown to 
stimulate leukemic cells to grow in laboratory cultures, but we do not know whether rhIL-3 
administration can stimulate leukemic cell growth in humans. Therefore, if the tumor cells are not 
completely destroyed by the preparative regimen, rhGM-CSF or rhIL-3 may possibly cause relapse of 
your malignancy by stimulating surviving tumor cells in addition to normal white cells. 
Recombinant DNA Research, Volume 16 
[339] 
