3. Patients who are HIV + . 
4. Patients with cardiorespiratory instability. 
6. Evaluation and Counseling of Patient 
Patients will be referred for consideration of a gene therapy. The patient will be completely 
evaluated. The protocol will be discussed thoroughly with patient and family and all known risks to the 
patient described. The gene therapy procedure and alternative forms of therapy will be presented as 
objectively as possible and the risks and hazards of the procedure explained to the patient. Consent will 
be obtained using forms approved by the Institutional Review Board of the Fred Hutchinson Cancer 
Research Center. A summary of the conference will be dictated for the medical record detailing what 
was covered. 
7. Protocol Registration 
Patients will be assigned to a protocol by the Ward Coordinator who will register the patient 
with the Registration Office (667-4728) between 8:30 am and 4:00 pm, Monday through Friday. At 
other times, registration should be obtained by calling the FHCRC’s Nurses’ Station at 667-5001 and 
ask for the registrar to be bellboyed. 
8. Plan of Treatment 
A. Treatment diagram 
Marrow aspiration (OPD) and establishment of LTMC stromal layer, day 1 
I 
rhG-CSF, 16 pg/kg/day s.c., days 11-14 
I 
Central venous catheter placement, day 11 (OPD) 
Peripheral blood cell (PBC) collections, day 14 and 15 
I 
Enrichment of PBC for CD34+ cells, day 15 
I 
Transduction of CD34+ PBC with GC-gene containing retrovirus vector supernatant, 
days 15-20 
I 
Analysis of pooled supernatants from transduced cells for replication competent virus 
and of a PBC sample for sterility and transduction efficiency, day 20 
I 
After obtaining negative gram stain, infusion of transduced PBC, day 20 
Patient follow-up for 2 months (end of cycle 1) 
Repeat 2 more cycles 
B. G-CSF administration 
To mobilize peripheral blood stem cells, patients will receive 4 daily doses of 
recombinant human granulocyte colony stimulating factor (G-CSF) at a dose of 16 
Fg/kg/day by subcutaneous injections. The first 3 doses will be administered in the 
Recombinant DNA Research, Volume 18 
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