count is >40,000 platelets/mm 3 . 
Other side effects occurring in approximately 2% of patients include 
anemia, fever, rash and abnormal liver function. If possible, autologous blood will be 
obtained and stored prior to treatment for transfusion should significant anemia 
develop secondary to GCV therapy or surgical blood loss. Fever and chills will be 
treated with acetominophen (650 mg every 4 hours) and rash with diphenhydramine 
(50mg every 6 hours). See appendix G for complete toxicity criteria. 
i 
There are a number of other possible toxicities related to GCV 
administration (e.g. the possibility of temporary or permanent inhibition of 
spermatogenesis) discussed in the monograph (Appendix F; page 38). These 
toxicities have generally occurred in immunosuppressed, ill individuals receiving long 
term administration. Our treatment protocol will use the known tolerated dose 
(lOmg/kg/day) in non-infected patients for only 14 days. These differences in patient 
population and treatment duration should minimize the likelihood of the development 
of potential toxicities cited. 
I 
Reporting of Adverse Reactions 
Adverse drug reactions (ADRs) to the IND Drug will be reported promptly to 
the Investigational Drug Branch (IDB), phone (301) 496-7957. ADR reports are 
required even if there is only a suspicion of a drug effect. Previously unknown Grade 
1 ,2 and 3 reactions will be reported to the NCI in writing using the “NCI Adverse 
Reactions Form for Investigational Agents” within 10 working days. Grade 4 (life- 
threatening) reactions and patient deaths while on treatment will be reported to the NCI 
by phone within 24 hours. A written report will follow within 10 working days. 
Written reports will be sent to: 
Investigational Drug Branch 
Cancer Therapy Evaluation Program 
P.O.Box 30012 
Bethesda, MD 20824 
[816] 
Recombinant DNA Research, Volume 15 
