Recombinant DNA Advisory Committee - 7/31/90 
Dr. Gellert noted that a revised consent form had been presented 
to the HGTS at the July 30, 1990, meeting and that Dr. Childress 
would address suggested further revisions to this form. 
2 . That a stronger warning with regard to the potential 
for malignancy be inserted into the consent form; 
Dr. Gellert said this had been done. 
3. That a "stop criterion" of two therapy-related deaths 
be inserted into the protocol; 
Dr. Gellert said this had been done. 
4. "That intraperitoneal infusions not be utilized without 
further approval by this committee; 
Dr. Gellert said this was considered a hazardous procedure 
especially in immune deficient children. However, it had been 
decided by the HGTS that this could be viewed as a minor 
modification to the protocol if the proposed procedure for 
handling minor modifications to protocols were approved by the 
RAC. 
5. That proceeding to Phase 2B of the protocol would 
require approval by the IRB; 
Dr. Gellert said this has been agreed to by the members of the 
HGTS. 
6. That full data from the Milan experiments of Dr. 
Claudio Bordignon be provided for review by the 
subcommittee prior to a meeting of the RAC; 
Dr. Gellert said he would return to this topic for more 
discussion shortly. 
7. That a final version of the inclusion/exclusion 
criteria for patients to be accepted or not accepted 
into the protocol reflect items such as age and length 
of time on Polyethylene Glycol (PEG) -ADA; 
Dr. Gellert said this information had been provided on pages 51 
and 52 of the revised protocol and is included as handwritten 
notes on those pages. 
8. And that a specific plan for follow-up evaluation of 
the immunologic and clinical status of the patients be 
given. 
Recombinant DNA Research, Volume 14 
[117] 
