24618 
Federal Register / Vol. 59, -No. 90 / Wednesday, May 11, 1994 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research: 
Proposed Actions Under the 
Guidelines 
agency: National Institutes of Health, 
PHS. HHS. 
action: Notice of proposed actions 
under the NIH guidelines for research 
involving recombinant DNA molecules 
(51 FR 16958). 
summary: This notice sets forth 
proposed actions to be taken under the 
National Institutes of Health (NIH) 
Guidelines for Research Involving . 
Recombinant DNA Molecules (51 FR 
16958). Interested parties are invited to 
submit comments concerning these 
proposals. These proposals will be 
considered by the Recombinant DNA 
Advisory Committee at its meeting on 
June 9-10, 1994. After consideration of 
these proposals and comments by the 
Recombinant DNA Advisory Committee, 
the Director of the National Institutes of 
Health will issue decisions in 
accordance with the NIH Guidelines. 
DATES: Comments received by May 26, 
1994, will be reproduced ana 
distributed to the Recombinant DNA 
Advisory Committee for consideration 
at its June 9-10, 1994, meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA], 
building 31, room 4B11, National 
Institutes of Health, Bethesda, Maryland 
20892, or sent by FAX to 301^90-9839, 
All comments received in timely 
response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5 p.m. 
FOR FURTHER tNFORMATTON CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities, building 31, room 4B11, 
National Institutes of Health, Bethesda, 
Maryland 20892, (301) 496-9838. 
SUPPLEMENTARY INFORMA TKDN: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
I. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Sobol and 
Royston 
In a letter dated October 6, 1993, Drs. 
Robert Sobol and Ivor Royston of the 
•San Diego Regional Cancer Center, San 
Diego, California, submitted the human 
gene transfer protocol entitled: Injection 
of Glioblastoma Patients vyith Tumor 
Cells Genetically Modified to Secrete 
Interleukin-2 (11^2): A Phase I Study to 
the Recombinant DNA Advisory 
Committee for formal review and 
approval. At the December 2-3, 1993, 
meeting, the Recombinant DNA 
Advisory Committee disapproved the 
original protocol. The majority of the 
Recombinant DNA Advisory Committee 
members concluded that the preclinical 
data derived ft’om a previous single 
patient protocol was inadequate to 
justify the experiment. The motion to 
disapprove the protocol passed by a 
vote of 10 in favor, 5 opposed, and 1 
abstention. 
In a letter dated April 8, 1994, Drs. 
Sobol and Royston submitted a revised 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Curiel 
In a letter dated April 13, 1994, Dr. 
David Curiel of the University of 
Alabama, Birmingham, Alabama, 
submitted the human gene transfer 
protocol entitled: Phase I Trial of a 
Polynucleotide Vaccine to Human 
Carcinoembryonic Antigen in Patients 
with Metastatic Colorectal Cancer to the 
Recombinant DNA Advisory Committee 
for formal review and approval. 
in. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Evans and 
Robbins 
In a letter dated April 13, 1994, Drs. 
C. H. Evans and Paul Robbins of the 
University of Pittsburgh, Pittsburgh, 
Pennsylvania, submitted the human 
gene transfer protocol entitled: Clinical 
Trial to Assess the Safety, Feasibility, 
and Efficacy of Transferring a 
Potentially Anti-arthritic Cytokine Gene 
to Human Joints with Rheumatoid 
Arthritis to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
rV. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Hcsiop, Brenner, 
and Krance 
In a letter dated April 6, 1994, Drs. 
Helen Heslop, Malcolm Brenner, and 
Robert Krance of the St. Jude Children’s 
Research Hospital, Memphis, 
Tennessee, submitted the human gene 
transfer protocol entitled: Use of Double 
Marking with Retroviral Vectors to 
Determine Rate of Reconstitution of 
Untreated and Cytokine Expanded 
CD34(+) Selected Marrow Cells in 
Patients Undergoing Autologous Bone 
Marrow Transplantation to the 
Recombinant DNA Advisory Committee 
for formal review and approval. 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Lyerly 
In a letter dated April 12, 1994, Dr. H. 
Kim Lyerly of Duke University Medical 
Center, Durham, North Carolina, 
submitted the human gene transfer 
protocol entitled: A Pilot Study of 
Autologous Human Interleukin-2 Gene 
Modified Tumor Cells in Patients with 
Refractory or Recurrent Metastatic 
Breast Cancer to the Recombinant DNA 
Advisory Committee for formal review 
and approval. 
VI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Drs. Econqmou, 
Glaspy, and McBride 
In a letter dated April 11, 1994, Drs. 
James Economou, John Glaspy, and 
William McBride of the University of 
California, Los Angeles, California, 
submitted a human gene transfer 
protocol entitled: A Phase I Testing of 
Genetically Engineered Interleukin-7 
Melanoma Vaccines to the Recombinant 
DNA Advisory Committee for formal 
review and approval. 
VIL 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 Freedman of M.D. Anderson 
Cancer Center, Houston, Texas, 
submitted the human gene transfer 
protocol entitled: Use of a Retroviral 
Vector to Study the Trafficking Patterns 
of Purified Ovarian Tumor Infiltrating 
Lymphocyte (TIL) Populations Used in 
Intraperitoneal Adoptive 
Immunotherapy of Ovarian Cancer 
Patients: A Pilot Study to the 
Recombinant DNA Advisory Committee 
for formal revievv and approval. At its 
June 7-8, 1993, meeting the 
Recombinant DNA Advisory Committee 
deferred the protocol until the 
investigators return to the full 
Recombinant DNA Advisory Committee 
with the following: 
(1) Data demonstrating efficient 
transduction of TIL, 
(2) Sufficient information regarding 
demonstration of selectivity, i.e., 
specific trafficking of TIL to tumor, 
(3) Complete statistical analysis, 
(4) Revised Informed Consent 
document in simplified language, and 
(5) Address concerns about patient 
responsibility for research-related costs. 
The motion to defer the protocol 
[3fX)l 
Recombinant DNA Research, Volume 19 
