#531 
FRED HUTCHINSON CANCER RESEARCH CENTER 
UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE, DIVISION OF ONCOLOGY 
(2/12/91) 
1. Phase I/H Study of the Use of Recombinant Human Interleukin 3 (rhJL3) Stimulated 
Peripheral Blood Progenitor Cell Supplementation in Autologous Bone Marrow Transplantation 
in Patients with Breast Cancer or Hodgkin Disease 
Investigators : John Nemunaitis, M.D., Associate in Clinical Research, FHCRC; J. Singer, MD., 
Professor of Medicine, UW (764-2709); CD. Buckner, M.D., Professor of Medicine, UW (467- 
4324); Associates: F.R. Appelbaum, M.D., Professor of Medicine, UW (467-4412); C. Anasetti, 
Assistant Member, FHCRC (467-5047); R. Andrews, M.D., Assistant Professor of Pediatrics, 
UW (467-4263); W. Bensinger, M.D., Associate Professor of Medicine, UW (467-4933); R. Hill, 
M.D., Associate Clinical Professor of Medicine, UW (467-4347); R. Storb, M.D., Professor of 
Medicine, UW (467-4407); K. Sullivan, M.D., Associate Professor of Medicine, UW (467-4416); 
E.D. Thomas, M.D., Professor of Medicine, UW (467-4329); JA. Hansen, M.D., Professor of 
Medicine, UW (467-5111). 24-hour phone 206/467-4369. Study Nurse 583-1986. 
2. Introduction 
Delayed neutrophil and platelet recovery after autologous bone marrow transplantation 
(BMT) correlate with increased infectious and bleeding complications. Despite enhanced 
n ophil and platelet recoveiy with rhGM-CSF therapy following BMT, the time of 
pancytopenia remains significant This protocol will be done in two phases. First peripheral 
blood cells will be administered to patients receiving rhGM-CSF after autologous BMT. 
Second, patients will receive peripheral blood cells pre-stimulated with rhIL3 followed by 
autologous BMT and rhGM-CSF. The purpose of this study is to evaluate two methods of 
potentially reducing the time in which the ANC remains below 100 mm 3 after ABMT using a 
combination of peripheral blood cells, bone marrow and cytokines. 
3. Background 
Morbidity and mortality of BMT is correlated with the duration and severity of 
myelosuppression. Patients have a substantial risk of bleeding and infection preceding marrow 
recovery (1-5). Possible methods of reducing the duration and severity of myelosuppression 
include stimulation of recovering hematopoietic cells with cytokines such as rhGM-CSF (6,7,8), 
rhG-CSF (10), rhILl (11), rhIL3 (12), and combinations of these (13-16). In Seattle, a double 
blinded randomized prospective trial administering rhGM-CSF or placebo to patients with 
lymphoid malignancy after autologous BMT was recently completed. Results of median values 
are shown below: 
Day 
ANC >1000 
Day ANC 
Day pit 
# pit 
# rbc 
Max 
Day 
>100 
indep 
units 
units 
creat. 
Discharge 
GM-CSF (n=22) 
19 
11 
21 
66 
6 
1.0 
25 
Placebo (n=19) 
27 
11 
30 
104 
11 
1.6 
33 
I lue 
0.03 
.38 
0.002 
0.027 
0.029 
0.039 
.006 
Recombinant DNA Research, Volume 16 
[331] 
