8.1.3 
Dose of GMT 
A dose escalation strategy will be utilized for this trial. 
The patients will receive 1 x 10 7 autologous IL-2 GMT 
cells by subcutaneous injection at week 0. 
If a sufficient number of autologous IL-2 GMT cells are 
recovered and available at week 4, patients will receive 
5 x 10 7 cells subcutaneously. 
If a sufficient number of autologous IL-2 GMT cells are 
recovered and available at week 8, patients will receive 
1 x 10 8 cells subcutaneously. 
If a sufficient number of autologous IL-2 GMT cells are 
recovered and available at week 12, patients will receive 
5 x 10 8 cells subcutaneously. 
8.1.4 Duration of GMT therapy 
GMT will be administered every 4 weeks at weeks 0, 4, 8 
and 12. 
9.0 MANAGEMENT OF INTERCURRENT EVENTS 
9.1 Concomitant Medications 
Chemotherapy, anti-estrogen therapy, other immunotherapy, 
and radiotherapy are not permitted while the patient is on study 
(screening through week 24). After meeting the 
inclusion/exclusion criteria, all other medications deemed 
appropriate for the patient by the investigator may be 
administered to the patient. At baseline, all medications that 
patients have used the past thirty days will be recorded. At 
subsequent visits, any additions or changes to medications, 
including blood products, will be documented on the 
appropriate Case Report Form. 
9.2 Risks And Toxicities Related To Autologous IL-2 GMT 
Injection site reactions have been observed in patients receiving 
subcutaneous GMT. Clinical follow-up of injection sites will be 
done at weeks 1 ,5, 9, andl3. Injection sites should be rotated. 
In general, systemic adverse effects have not been attributed to 
injected IL-2 GMT cells. No measurable toxicity was observed in 
animal studies. In human studies of IL-2 GMT cells, the adverse 
events observed have been primarily local reactions. 
Safety variables to be monitored include all known side effects 
and toxicities associated with active immunotherapy, rIL-2 
administration or gene therapy. Vital signs will be followed 
closely during administration of gene modified tumor cells for 
any hypotensive or hypertensive episodes. Subjective 
symptoms such as headache, fatigue, nausea/vomiting, chills. 
[2561 
Recombinant DNA Research, Volume 20 
