a. CBC with Differential count 
b. Immunologic evaluation to include: 
a) Serum immunoglobulins 
b) DTH skin test panel 
c) Isohemagglutinin titer 
c. PCR on mononuclear cell DNA for vector sequences 
d. Western analysis of serum for antibody to retroviral antigens 
e. If at any time a malignancy develops, involved tissue to be analyzed for vector DNA 
It is understood that the performance of an individual study or test as specified in this 
protocol is subject to factors such as patient compliance, scheduling difficulties, equipment 
malfunction, or the clinical judgnient of the principal investigator or patient care physician, 
and that a test therefore may not be done in an individual instance with no violation of the 
protocol. However, any systematic modification of the original protocol in this regard, whether 
related to patient safety or not, will be submitted to the IRB for approval. 
9.0 Off-Study Criteria 
The development of any grade 3 or 4 toxicity that is not easily correctable. The toxicity sheet 
for this study (similar to the one used in the approved protocol 86-C-183 except for 
age/weight appropriate pediatric modifications) is included in the Appendix-Common 
Toxicity Criteria. This protocol will be terminated if two (2) treatment related deaths 
occur. 
10.0 Evaluation of Results 
10.1 Criteria for Response 
Laboratory or clinical evidence of improved immune function such as development of more than 
one new positive delayed type hypersensitivity skin test to environmental antigens or 
immunogens, the development of antigen specific proliferative responses in vitro to antigens 
were no responsiveness existed prior to therapy, the production of specific antibodies to 
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