Federal Register / Vol. 58. No 158 / Wednesday, August 18, 1993 / Notices 
44099 
therapy protocol for review and 
approval. 
III. Addition to Appendix D of the N1H 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Das Gupta and 
Cohen 
In a letter dated February 26, 1993, 
Drs. Tapas K. Gas Gupta and Edward P. 
Cohen of the University of Illinois 
College of Medicine, Illinois, and Dr. 
Jon M. Richards of the University of 
Chicago, Chicago, Illinois, submitted a 
human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
title of this protocol is: Immunization of 
Malignant Melanoma Patients With 
lnterleukin-2-Secreting Melanoma Cells 
Expressing Defined Allogeneic 
Histocompatibility Antigens. 
During the June 7-8, 1993, 
Recombinant DNA Advisory Committee 
meeting, approval of the protocol was 
deferred until the investigators returned 
to the committee with the following: 
(1) Data demonstrating the efficiency 
of transduction in Mel-4 cells; 
(2) Data demonstrating viability, IL-2 
production; and in vivo murine effect of 
irradiated transduced cells (either 5,000 
or 10,000 rads); 
(3) Rationale for ethnic eligibility 
criteria; 
(4) Complete responses to the Points 
to Consider, and 
(5) RCR testing data demonstrating 
safety of the vector preparation. 
On July 13, 1993. Drs. Tapas K. Das 
Gupta and Edward P. Cohen, University 
of Illinois at Chicago, Chicago, Illinois, 
resubmitted a human gene therapy 
protocol for formal review and approval. 
The revised title of this.protocol is: Pilot 
Study of Toxicity of Immunization of 
Patients with Unresetable Melanoma 
with IL-2 Secreting Allogeneic Human 
Melanoma Cells. 
IV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Cassileth, 
Podack, Sridhar, and Savaraj 
In a letter dated December 22, 1992, 
Drs. Peter A. Cassileth and Eckhard 
Podack, University of Miami, Miami, 
Florida, submitted a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is -.Phase I Study of Transfected 
Cancer Cells Expressing the Interleukin- 
2 Gene Product in Limited Stage Small- 
cell Lung Cancer. 
During the Match 1-2, 1993, 
Recombinant DNA Advisory Committee 
meeting, approval of the protocol was 
deferred until the investigators returned 
to the committee with the following: 
(1) A definition of the clinical 
endpoints; 
(2) Clonogenic assays using irradiated 
tumor cells; and 
(3) A revised Informed Consent 
document, including a statement that 
some patients selected for gene therapy 
will require a second surgical procedure 
to obtain material for the study. 
In a letter dated July 14. 1993, Drs. 
Peter Cassileth, Eckhard R. Podack, Kasi 
Sridhar, and Niramol Savaraj of the 
University of Miami School of 
Medicine, Miami, Florida, resubmitted a 
human gene therapy protocol for formal 
review and approval. 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Kun, Sanford, 
Brenner, Heideman, Oldfield 
On July 12. 1993, Drs. Larry E. Kun, 
R.A. Sanford. Malcolm Brenner, and 
Richard L. Heideman of St. Jude 
Children’s Research Hospital Memphis, 
Tennessee, and Dr. Edward H. Oldfield 
of the National Institutes of Health, 
Bethesda, Maryland, 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 Recurrent Pediatric Brain Tumors. 
VI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Wong-Staal, 
Poeschla 
In a letter dated July 14, 1993, Drs. 
Flossie Wong-Staal, Eric Poeschla, and 
David Looney of the University of 
California, San Diego, La Jolla, 
California, submitted 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 Clinical Trial to 
Evaluate the Safety and Effects in HIV- 
1 Infected Humans of Autologous 
Lymphocytes Transduced with a 
Ribozyme that Cleaves HIV-l RNA. 
VII. Amendment to Appendix D-XXVII 
of the NIH Guidelines Regarding a 
Human Gene Transfer Protocol/Drs. 
Greenberg, Riddell 
On July 9, 1993, Drs. Philip Greenberg 
and Stanley R. Riddell of the Fred 
Hutchinson Cancer Research Center, 
Seattle, Washington, indicated their 
intention to submit a major modification 
to a human gene transfer protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The 
current title of this protocol is: A Phase 
I Study of Cellular Adoptive 
Immunotherapy Using Genetically 
Modified CD8+ HIV-Specific T Cells for 
HIV-Seropositive Patients Undergoing 
Allogeneic Bone Marrow Transplant. 
The revised title of this protocol is: 
Phase I Study to Evaluate the Safety of 
Cellular Adoptive Immunotherapy using 
Genetically Modified CD8+ HIV- 
Specific T Cells in HIV Seropositive 
Individuals. 
VIII. Addition to Appendix D of the 
NIH Guidelines Regarding Semliki 
Forest Virus/Dr. Temple 
In a letter dated February 8, 1993, Dr. 
Gary F. Temple of Life Technologies, 
Inc., Gathersburg, Maryland, submitted 
a request for a reduction in physical 
containment from Biosafety Level 3 to 
Biosafety Level 2 for a Semliki Forest 
Virus (SFV) vector expression system. 
During the June 7-8, 1993, 
Recombinant DNA Advisory Committee 
meeting, approval was deferred until the 
investigators returned to the Committee 
with the following: 
(1) A product information sheet 
informing customers of the potential 
health risk of the expression system, 
standard methods to be used for virus 
inactivation, a helper virus assay to 
detect SFV, and a description of 
symptoms and procedures to be 
followed in the event that SFV infection 
occurs in a laboratory worker (including 
methods to prevent transfer to insect 
vectors and environmental spread); and 
(2) SFV inactivation data. 
In a letter dated February 8, 1993, Dr. 
Gary F. Temple of Life Technologies. 
Inc., Gaithersburg, Maryland, 
resubmitted a request for a reduction in 
physical containment from Biosafety 
Level 3 to Biosafety Level 2 for an SFV 
vector expression system. 
IX. Amendments to Section III and 
Appendix F of the NIH Guidelines 
Regarding the Cloning of Toxin 
Molecules 
In a letter dated July 28, 1993, Dr. 
Nelson A. Wivel, Director, Office of 
Recombinant DNA Activities (ORDA). 
National Institutes of Health, Bethesda, 
Maryland, requested amendments to 
sections III, IV. and V. and appendices 
C and F regarding the review process for 
experiments involving the cloning of 
toxin molecules. 
X. Report on Minor Modifications to 
NIH-Approved Human Gene Transfer 
Protocols 
Dr. LeRoy Walters, Chair of the 
Recombinant DNA Advisory Committee, 
will present an update on minor 
modifications to NIH-approved human 
gene transfer protocols. 
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