Federal Register / Vol. 58, No. 84 / Tuesday, May 4, 1993 / Notices 
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Secreting Melanoma Cells Expressing 
Defined Allogeneic Histocompatibility 
Antigens. 
III. Addition to Appendix D of die N1H 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Galpin, Casciato 
On April 9, 1993, a human gone 
therapy protocol was submitted for Drs. 
Jeffrey E. Galpin of tho University of 
Southern California. Los Angeles, 
California, and Dr. Dennis A. Cosciato of 
the University of California, Los 
Angeles, California, by Dr. Bruce 
Merchant, Viagene, Inc, San Diego, 
California (sponsor of the protocol), to 
die Recombinant DNA Advisory 
Committee for formal review and 
approval. The title of this protocol is: A 
Preliminary Study to Evaluate the Safety 
end Biologic Effects of Murine Retroviral 
Vector Encoding HIV-1 Genes [ HTV- 
IT(V)) in Asymptomatic Subjects 
Infected with HIV-1. 
IV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dre. Karlsson, 
Dunbar, Kohn 
Ln a letter dated April 10, 1993, Drs. 
Stefan Karlsson end Cynthia Dunbar of 
the National Institutes of Health, 
Bothesda, Maryland, and Dr. Donald B, 
Kohn of Childrens Hospital Los 
Angeles, Los Angeles, California, 
submitted a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and epproval. The title of this protocol 
is: Retroviral Mediated Transfer of the 
cDNA for Human Giucocerebrosidase 
into Hematopoietic Stem Ceils of 
Patients with Gaucher Disease. 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy ProtocoL/Dr. Ban-anger 
In a letter dated March 26, 1693, Dr. 
John A. Barranger of the University of 
Pittsburgh, Pittsburgh, Pennsylvania, 
indicated his intention to submit a 
human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol Is: Gene Therapy 
for Gaucher Disease: Ex Vivo Gene 
Transfer and Autologous 
Transplantation ofCD34(+) Cells. 
VI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. RafTel, Culver 
In a letter dated April 5, 1993, Dr. 
Corey Raffel of the Childrens Hospital 
Los Angeles, Los Angeles, California, 
and Dr. Kenneth Culver of Iowa 
Methodist Medical Center, Des Moines, 
low'd, submitted a human gene therapy 
protocol to the Recombinant DNA 
Advisor)' Committee for formal review 
and approval. The title of this protocol 
is: Gene Therapy for the Treatment of 
Recurrent Pediatric Malignant 
Astrocytomas with In Vivo Tumor 
7 ransduction with the Herpes Simplex 
Ti.ymidine Kinase Gene. 
Vli. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Hesdorffer, 
Antman 
In a letter dated March 8, 1993, Dr. 
Arthur Bank of Columbia University, 
New York, New York, indicated the 
intention of Drs. Charles Hesdorffer and 
Karen Antman of the Columbia 
University, College of Physicians and 
Surgeons, New York, New York, to 
submit a human gene therapy protocol 
to the Recombinant DNA Advisory 
Committee for formal review and 
approval. The title of this protocol is: 
Human MDR Gene Transfer in Patients 
with Advanced Cancer. 
VIII. Addition to Appendix D of the 
NIH Guidelines Regarding a Human 
Gene Transfer Protocol/Dr. Freedman 
In a letter dated March 22, 1993, Dr. 
Ralph S. Freedman of the University of 
Texas MD Anderson Cancer Center, 
Houston, Texas, indicated the intention 
to submit a human gene transfer 
protocol to the Recombinant DNA 
Advisor)’ Committee for formal review 
and approval. The title of this protocol 
is: Use of a Retroviral Vector to Study 
the Trafficking Patterns of Purified 
Ovarian TIL Populations Used in 
Intraperitonecl Adoptive 
Immunotherapy of Ovarian Cancer 
Patients — A Pilot Study. 
EX. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Ilan 
In a letter dated April 10, 1993, Dr. 
Josoph Ilan of the Case Western Reserve 
University School of Medicine and 
University Hospitals of Cleveland, 
Cleveland, Ohio, submitted a human 
gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Gene Therapy 
for Human Brain Tumors Using 
Episome-Based Antisense cDNA 
Transcription of Insulin-Like Growth 
Factor I. 
X. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Nabel 
In a letter dated April 9, 1993, Dr. 
Gary J. Nabel of the University of 
Michigan Medical Center, Ann Arbor, 
Michigan, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Immunutherapy for Cancer 
by Direct Gene Transfer into Tumors. 
XI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Nabel 
In a letter dated April 9, 1993, Dr. 
Gary J. Nabel of the University of 
Michigan Medical Center, Ann Arbor, 
Michigan, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: A Molecular Genetic 
Intervention for AIDS — Effects of a 
Transdominant Negative Form of Rev. 
XII. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Seigler 
In a letter dated April 9, 1993, Dr. 
Hilliard F. Seigler of the fluke 
University Medical Center, Durham, 
North Carolina, resubmitted a human 
gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: A Phase I Trial 
of Human Gamma Interferon- 
Transduced Autologous Tumor Cells in 
Patients With Disseminated Malignant 
Melanoma. 
XIII. Amendment to Appendix D-XV of 
the NIH Guidelines Regarding a Human 
Gene Therapy Protocol/Dr. Blaese 
On April 8, 1993, an amendment to 
the human gene therapy protocol was 
submitted for Dr. R. Michael Blaese of 
the National Institutes of Health, 
Bethesda, Maryland, by Dr. Craig A. 
Mullen of the National Institutes of 
Health, Bethesda, Maryland, to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Treatment of 
Severe Combined Immune Deficiency 
(SCID) due to Adenosine Deaminase 
(ADA) Deficiency with CD34(+) 
Selected Autologous Hematopoietic 
Stem Cells. 
XTV. Addition to Appendix D of the 
NIH Guidelines Regarding Semlild 
Forest Virus/Dr. Temple 
In a letter dated February 8, 1993, Dr. 
Gary F. Temple of Life Technologies, 
Inc., Gaithersburg, Maryland, submitted 
a request for a reduction in physical 
containment from Biosafety Level 3 to 
Biosafety Level 2 for a Semlild Forest 
Virus vector expression system. 
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