inserted into either a peripheral vein or, if no peripheral access is available, into a 
central vein. In accordance with the randomization, either 1 x 10^, 1 x 10^, or 1 x 10*® 
expanded lymphocytes will be infused over 60 minutes. Patients will be under close 
inpatient observation for a total of 4 hours from the start of the infusion, and will be 
seen as an outpatient over the next 3 days. 
Vital signs will be taken pre-infusion, every 15 minutes during the infusion, then 
hourly for the remainder of the 4-hour observation period. Oxygen saturation by pulse 
oximetry will be taken continuously during the infusion and 4-hour observation period. 
Patients who develop fever, chills, or muscle aches may receive aspirin, ibuprofen, or 
acetaminophen as indicated. Acetaminophen will be used if the patient does not tolerate 
aspirin or ibuprofen. The development of a rash will be treated initially with 
diphenhydramine PO. Cell infusions will be slowed or discontinued depending upon 
the severity of the reaction. In the event of a severe reaction, emergency life support 
measures will be immediately undertaken. Patients who experienced reactions to a 
previous infusion may be premedicated 30 minutes prior to future infusions with either 
aspirin, acetaminophen, or diphenhydramine. Meperidine will be used for more severe 
chills and muscle aches that do not quickly respond to antipyretics and antihistamines. 
Patients experiencing rapid disease progression or dose-limiting toxicity to the 
lymphocyte infusions (as defined in Section 11.1) during Treatment Period I will 
terminate participation but will go through safety observation. These patients will not 
participate in Treatment Period II. Every effort will be made to retain patients on-study 
as long as treatment is not felt to be contraindicated. These dropouts will not be 
replaced. 
Criteria for the advancement of dose escalation and definitions of dose-limiting toxicity, 
are outlined in Section 11.1. In the event of a marginal toxicity rate at any one dosage 
level, three additional patients may be enrolled in order to further define the trend as 
outlined in Section 1 1 . 1 .4. 
No patient will proceed into Treatment Period II until patients in all 3 cohorts have been 
assessed for safety. Therefore, there will be a variable period of delay between Periods 
I and II during which the patients will still be considered on-study and on whom 
follow-up will be maintained. 
6.2 Treatment Period II 
After the requisite number of patients in all treatment cohorts have received their single 
Period I infusion of cells and each cohort assessed for the rate of immediate dose- 
limiting toxicity (DLT), the seropositive twins who did not exhibit DLT may continue 
into Treatment Period II after at least 8 weeks of observation. 
Patients will be reassessed for eligibility vis a vis the criteria outlined in Section 4; those 
who are no longer eligible will terminate the study at that time. Patients originally 
randomized to cohort 0 will receive up to 6 additional infusions of unmodified 
lymphocytes at the same dose of 1 x 10'^ cells, given every 8 weeks. Patients in 
cohorts 1 , 2, and 3 will all receive the highest cell dose that was deemed safe in Period 
I according to the rules in Section 11.1. Up to 16 additional patients may be newly 
randomized to receive either 10*® unmodified lymphocytes (4 patients) or modified 
lymphocytes at the highest dosage deemed safe in Period 1(12 patients). 
Subsequent infusions in Period II may be performed on an outpatient basis at the 
discretion of the Principal Investigator. For outpatient infusions, patients will be 
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