CHRONOLOGY OF REVIEW OF HUMAN GENE TRANSFER PROPOSAL 
June 10, 1988: Submission of Amendment to Approved Clinical 
Research Project to two NIH Clinical Research Subpanels; original 
project title: "The Treatment of Patients with Advanced Cancer 
Using Cyclophosphamide, Interleukin-2 and Tumor Infiltrating 
Lymphocytes" (tab 1333, p. 16). 
June 15, 1988: submission of proposed amendment to NIH 
Institutional Biosafety Committee (tab 1333, p. 15). 
June 20, 1988: review of proposed amendment by National Cancer 
Institute Clinical Research Subpanel; outcome: approval with one 
stipulation and 10 recommendations (tab 1333, p. 100, plus new 
minutes in table folder) ; part of stipulation was that final 
version of amendment be submitted to Subpanel for "final 
consideration. " 
June 21, 1988: review of proposed amendment by National Heart, 
Lung, and Blood Institute Clinical Research Subpanel; outcome: 
approval with three stipulations; in one stipulation, Subpanel 
deferred to RAC on "procedures needed to assure that no 
infectious virus particles remain in the preparation"; in 
another, Subpanel made final approval of proposal "contingent 
upon the investigators' report of ongoing experiments to 
demonstrate that the N2 infected cells are representative of the 
major group [groups?] of uninfected TIL cells" (tab 1333, p. 
101 ) . 
July 5, 1988: first mailing to Human Gene Therapy Subcommittee 
by NIH Office of Recombinant DNA Activities (ORDA) ; contents: pp. 
9-94b under Tab 1333. 
July 13, 1988: review of proposed amendment by NIH Institutional 
Biosafety Committee; extended discussion of part of proposed 
study involving human subjects (more than seven pages in 
committee minutes); outcome: approval "conditional upon the 
approval of the RAC and the receipt of the results from the 
preliminary in vivo work in the mouse"; signed version of minutes 
not available before RAC meeting. 
July 13, 1988: formal submission of proposed amendment to ORDA 
by Drs. Anderson, Blaese, and Rosenberg (tab 1333, p. 99). 
July 18, 1988: second mailing to Human Gene Therapy Subcommittee 
by ORDA; contents: pp. 95-205 under Tab 1333. 
July 29, 1988: scheduled meeting of RAC's Human Gene Therapy 
Subcommittee; review of proposed amendment was the major item of 
business for Subcommittee; presentations by Drs. Anderson, 
Blaese, and Lotze (for Dr. Rosenberg); discussion with 
investigators followed by Subcommittee deliberations; Nieman 
Recombinant DNA Research, Volume 13 [223] 
