4. 
PUBLIC HEALTH CONSIDERATIONS 
Dr. James Wyngaarden, then Director of the NIH, has stated in 
the Federal Register (Volume 54, No. 47, March 13, 1989, p. 10508) 
that: 
"Through data obtained in animal experiments, the 
investigators have demonstrated to the satisfaction of the 
Recombinant DNA Advisory Committee that the use of amphotropically 
packaged retroviral vectors does not pose a public health risk to 
patients or to health care personnel even in the event of 
accidental exposure to experimental material. Therefore, I have 
determined that this protocol does not present a risk to public 
health or to the environment" (3) . 
Since the vector is not competent to replicate outside of 
packaging cell lines, there is no chance of vertical transmission 
or chance to alter future generations. Since the vector to be used 
is the same as that used in previously approved trials of M. 
Brenner and S. Rosenberg, no new public health converns should be 
raised by this protocol. 
5. QUALIFICATIONS OF INVESTIGATOR, ADEQUACY OF LABORATORY AND 
CLINICAL FACILITIES 
The M.D. Anderson Cancer Center, Department of Hematology, 
Bone Marrow Transplantation Unit conducts more than 250 
transplantations/year. The Department of Hematology has 80 in- 
patient beds, 18 laminar flow rooms, and 77,000 square feet of 
outpatient space which services over 25,000 outpatient visits/year. 
Our service sees more than 650 new lymphoma patients and over 450 
new leukemia patients/year. Dr. Deisseroth has been involved in 
bone marrow transplants for more than 14 years. Dr. Champlin, a 
co-investigator and a collaborator, is also an international 
authority in bone marrow transplants. Dr. Deisseroth 's CML 
autologous bone marrow transplantation program is funded by the NCI 
of the National Institutes of Health by a program project grant 
(The Therapy of CML) of which Dr. Deisseroth is the principal 
investigator. Dr. Malcolm Brenner, whose AML protocol was 
approved, is a collaborator. Dr. W. French Anderson, who is a 
leader in the field, is also a collaborator. 
The LNL6 retrovirus is obtained from Genetic Therapy, Inc. , 
the same source as that used for the N2-TIL human clinical gene 
transfer experiments, and the Brenner AML trial. Clinical marrow 
culture and gene transfer PCR and Southern blot experiments will be 
conducted at the U.T. M.D. Anderson Cancer Center laboratories of 
Dr. Deisseroth. The data presented in this application show that 
the investigators are competent to introduce the vector into CML 
cells and that they can detect the presence. 
Recombinant DNA Research, Volume 14 
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