10.5 
Measurable disease. 
10.6 Informed consent conforming to institutional guidelines. 
10.7 Exclusion criteria 
10.7.1 Serious localized or systemic infection 
10.7.2 HIV positivity 
11.0 OUTLINE OF THERAPY 
11.1 Bone Marrow Harvest 
Patients will have marrow harvested under general anesthesia using aseptic 
techniques. Multiple aspirates will be obtained from the iliac crest(s) 
(posterior and/or anterior) into heparinized syringes and pooled in heparinized 
tissue culture media. A volume of blood and marrow will be aspirated 
sufficient to yield at least 3 x 10® nucleated cells per kilogram of body weight. 
The specimen will be filtered through differing size meshes to remove bony 
particles and aliquots will be obtained prior to the addition of cryoprotectants 
for in vitro laboratory studies. Seventy percent of the bone marrow cells will 
be suspended for cryopreservation with 10% dimethyl sulfoxide (DMSO) in 
the liquid phase of nitrogen and stored for future reinfusion into the patient. 
Thirty percent will be used for transduction (section 5.2). At the time of 
reinfusion both transfected and untreated frozen marrow will be rapidly 
thawed in a 37 ' C water bath at the bedside and immediately infused without 
further manipulation 48 hours after the completion of chemotherapy. 
11.2 High-Dose Chemotherapy 
For patients with less than 1,000 mg/m^ of previous cumulative cisplatin: 
Carboplatin 700 mg/mVday IV, over one hour q.o.d. x 3 
(Days -7, -5, -3) 
VP-16 500 mg/m^day IV, over 6 hours q.o.d. x 3 
(Days -6, -4, -2) 
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Recombinant DNA Research, Volume 14 
