normal (ULN) , patients should have a 
hepatitis B surface antigen (HBsAG) test 
prior to study entry. Patients may not enter 
the study if HBsAG is positive.] 
► PT and PTT not more than 1.5 times the ULN 
► Serum Amylase < 1.5 times the ULN 
► Bilirubin <2.5 mg/dL 
► Triglyceride < 400 mg/dl 
4.14 Ability to give informed consent 
4.15 Normal cardiac function by history and exam 
4.16 Resting transcutaneous oxygen saturation > 90% on 
room air 
4.17 Karnofsky Performance Status > 40 (see Appendix 
IV) 
Although there are no blood count criteria for inclusion in this 
study, preference will be given to patients with significant 
marrow failure as reflected by anemia, neutropenia, and/or 
thrombocytopenia. Furthermore, we intend to first enroll adults 
and older children, to the extent possible, before enrolling 
young children. 
4 . 2 Exclusion Criteria 
Patients who meet any one of the following criteria 
will be excluded from study entry: 
4.20 Patients presenting with acute leukemia or bone 
marrow aspirate revealing >10% blasts 
4.21 Pregnant or lactating females [all patients must 
practice adequate birth control and females of 
child-bearing potential must have a negative serum 
beta-HCG pregnancy test (within Day -7 to Day 0)] . 
4.22 Acute infection: any acute viral, bacterial, or 
fungal infection which requires specific therapy. 
Acute therapy must have been completed within 14 
days prior to study treatment. 
4.23 Hepatitis-B surface antigen positive patients. 
4.24 HIV- infected patients. 
4.25 Acute medical problems such as ischemic heart or 
lung disease that may be considered an 
unacceptable anesthetic or operative risk. 
4.26 Patients with any underlying conditions which 
would contraindicate therapy with study treatment 
(or allergies to reagents used in this study) . 
4.27 Patients < 25 kg weight or < 5 years of age 
4.28 Patients who elect bone marrow transplantation 
(see below, 13.0 Ethical Considerations) 
4 . 3 Concomitant Medication and Treatment 
All allowed medications or treatments should be kept to 
a minimum and recorded. All questions regarding 
concomitant medications should be referred to the 
principal investigator. 
4 . 4 Potential Risks and Discomforts Related to Evaluations 
Patients will require needle sticks for blood sampling. 
They will also undergo bone marrow aspiration and 
biopsy, with the associated risks of infection and 
bleeding . 
5.0 CLINICAL AND LABORATORY EVALUATIONS 
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