TABLE 15 CONTINUED 
Pericarditis /Pleural Effusions/Capillary Leak at 60ng/kg 
Pulmonary Embolism 
Hypoalbuminemia 
Reversible Thyroiditis 
Local Tox icities from GM-CSF Administration 
Pustular Eruption of Injection Site 
Necrotizing Vasculitis (Hemorrhagic Bullae at Injection Site) 
Erythema, pruritus at injection Site 
Recall Erythema at previous injection Site 
General papular rash 
Phlebitis at injection site 
14 
14 
16 
17 
11 
12 
12 
12 
12 
13,14,18 
References for Table 15 
1. Retro, et.al.: Lancet ii, 950, 1988 
2. Devereux, et.al.: Lancet, 1524, 1987 
3. Wood.A.J.J. N.E.J.M. 327:99-106,1992 
4. Bellheiin, et.al.: Blood 77. 700-711, 1991 
5. Neumaitis, et.al.: N.E.J.M. 324, 1773-1778, 1991 
6. Antin, et.al: Behring, Inst. MIH.83, 149-153, 1988 
7. Nathan, et.al.: N.E.J.M. 326, 417, 1992 
8. Drieces, et.al.: Am. Int. Med. 111:92, 1989 
9. Brandt, et.al: N.E.J.M. 318:869-876, 1988 
10. Vieres, et.al.: Am. Int. Med. 111:263, 1989 
11. Passweg: Am. Hemalol. 63:326-327, 1991 
12. Ruiz-Rodriguez: Arch. Dermatol. 126:1243-1244, 1990 
13. Steward, et.al.: Brit. J. Can, 59:142-149, 1990 
14. Hoelzer: Behring Inst. Proc. 83:134-138, 1988 
15. Lundemann, et.al.: Leukemia 8:606-607, 1990 
16. Kaczmarski: Brit. Med. J. 301:1312-1313, 1990 
17. Hackman: Lancet 338:541-542, 1991 
18. deVries: Lancet 338:517-518, 1991 
Potential Autoimmune Toxicities 
The potential of this form of therapy to induce late onset auto-immune 
disease makes Stage 3 of the trial essential in the study design--namely long- 
term follow up at the Johns Hopkins Oncology Center. Measurements and timing 
of clinical indicators of auto- immunity are delineated in Section 7. 
Using the RENCA murine RCC tumor model transduced with murine 
GM-CSF, we could detect no histologic evidence of induced glomerulonephritis 
or auto-immune tubular damage to the normal kidneys. Renal function did not 
deteriorate by serial creatinine determinations in these mice either (Appendix 
Recombinant DNA Research, Volume 17 
[319] 
