5% Dextrose and water and infused over one hour. 
Dosage and adjustments. The standard dose is 5 mg/kg b.i.d. when 
patients have a creatinine clearance > 80. If the CrCL is 50-79, the dose 
is 2.5 mg/kg b.i.d.. Daily CBC and platelet counts will be obtained during 
treatment. The drug should be stopped if the absolute granulocyte count 
falls below 750 or the platelets are less than 50,000. 
8.5 Grading of side effects and toxicity will be determined by the NCI 
“Common toxicity criteria” (Appendix B). 
8.6 To document the patient reported incidence and severity of side effects 
from treatment, each patient will be asked to complete a self-care diary. 
Each diary lists 23 possible side effects and includes space for patients 
to write in additional side effects. Patients also rate the efficacy of self- 
care activities in alleviating treatment side effects. In addition patients 
are asked to give an overall rating of how upsetting and disrupting are 
the side effects. The diary takes approximately 15 minutes to complete. 
The diary has been shown to have adequate variance and is acceptable 
to patients (24). It is currently being used with patients receiving 
traditional chemotherapy as well as inpatients receiving IL-2. The diary 
will be completed daily for the 7 day hospital stay for each treatment and 
at 1 week and 2 weeks following discharge. 
8.7 Retrovirallv transduced PA-1 cells. PA-1 cells will be monitored 
before vaccine freezing for the presence of replication competent murine 
retrovirus using the helper rescue assay. In addition, at the time of 
freezing an aliquot of cells will be taken from the batch and grown in 
culture for at least two additional months and then assayed for the 
presence of replication competent virus. 
9.0 Measurement of Effects 
9.1 Pretreatment immunologic evaluation. Active specific immunotherapy 
treatments are dependent upon an intact immune system in the host in 
order to respond to the vaccine. Patients with an impaired immune status 
due to advanced cancer, nutritional deficiency, or immunosuppressive 
agents are less likely to respond. The eligibility criteria help to avoid this 
problem but in addition the status of each patient’s immune system will 
be evaluated as below. Participation is not dependent on the outcome of 
these tests, but they will be used in analyzing the immunologic and 
clinical parameters. 
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