degree water bath. Total volume is expected to be 100-500 cc. Possible 
toxicides include volume overload, which can be treated by slowing the 
infusion and using diuretics, and transient dyspnea due to mast cell 
degranulation induced by DMSO, which can be treated with additional 
antihistamines and steroids. All patients will have their vital signs monitored 
ql5 minutes x 4 and q30 minutes x 2. Additional demerol and benadryl are to 
be used as needed. Hypotension is to be corrected with fluid and pulmonary 
symptoms with 2L/min supplemental oxygen. 
6.8.2 Infusion of Transduced CD34-Enriched Cells 
a) The cell vials will be removed from liquid nitrogen and thawed at 37°C in a 
water bath within a ziplock bag. 
b) Thawed cells will be transferred to a 50 cc conical tube in a laminar flow 
hood. 5 ml of heparinized TC199 will used to rinse each freeze tube and then 
will be added dropwise to the cells. Over a period of five minutes the cells will 
be diluted to a total volume of 30 ml with heparinized TCI 99. 
c) The cells will be drawn into a labelled 60cc syringe and a sample will be 
removed for counts and analyses. The stem cell concentrate will then be 
infused into the patient over 5 minutes. The above procedure will be repeated 
for each vial of transduced bone marrow or peripheral blood CD34-enriched 
cells. 
7.0 Dose Modifications 
Taxol or Vinblastine: Cycles will be delayed one week for an ANC < 1500/mm 3 or platelets 
<90, 000/mm 3 on the day that chemotherapy is due. The taxol or vinblastine dose will be 
escalated by 10% each cycle to achieve a nadir ANC <1000/mm 3 . The dose of taxol or 
vinblastine will be decreased by 10% for an ANC <500/mm 3 for >5 days or platelets 
<20,000/mm 3 during previous cycle. 
7.1 If after a one week delay, the ANC is <1 500/mm 3 or platelets <90, 000/mm 3 , treatment 
with taxol or vinblastine can be given as below: 
If ANC is: Taxol or Vinblastine Dose: 
1200-1499 75% 
900-1199 50% 
less than 900 no drug 
If platelet count is: Taxol or Vinblastine Dose: 
75,000 - 89,000 50 % 
<75,000 no drug 
Non-Hematologic Toxicitv : 
Grade 1 or 2: No dose reductions. 
Grade 3 or 4: Hold therapy until toxicity resolves and then give next cycle with a 25% 
dose reduction. 
Recurrent Grade 3 or 4 toxicity: Off-Study 
7.2 G-CSF Dose Modification: For Grade 3 toxicities that are, in the judgement of the 
Principal Investigator, due to G-CSF, the dose of G-CSF should be reduced to 50% 
of the original dose. For Grade 4 toxicities that are, in the judgement of the Principal 
Investigator related to G-CSF, the G-CSF should be stopped and not resumed. For 
toxicities of Grade 2 or less that are considered by the Principal Investigator to be 
related to G-CSF, an effort should be made to ameliorate the toxicity through use of 
acetaminophen and/or diphenhydramine. If a patient cannot tolerate a dose of 5.0 
(ig/kg G-CSF per day during BMT or 2.5fig/Kg during vinblastine treatment, the G- 
CSF will be stopped. 
Recombinant DNA Research, Volume 18 
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