I 
Nevertheless, accrual to a cohort will stop if 2 patients develop grade 3 or 
grade 4 toxicity (with the exception of local grade 3 toxicity which will not 
be considered dose-limiting, see below) . The next lower dose level will be 
declared the MTD providing no more than 1/6 has developed a dose-limiting 
toxicity. Local toxicity will be graded as follows: erythema and induration < 
20 mm, grade 1; erythema and induration greater than 20 mm but no ulcer, grade 
2; ulcer, or painful regional adenopathy, grade 3; permanent dysfunction 
related to local toxicity, grade 4 . 
2. The maximum concentration for mixing cells is 10 8 /ml. At the lo' 1 dose 
level, the cells will be brought up to 1 ml total volume. For the 10 7 and 10 8 
dose levels, each dose will be split into two 0.5 ml aliquots and injected 5 
centimeters apart (approximately 3 finger breadths) into the same extremity. 
Q 
At the 1CP dose level, each dose will require 10 separate injections of 1 ml 
placed 3 cm apart into the same extremity. All doseu will be injected 
subcutaneously in an extremity with intact draining lymph nodes. Injections 
will be given every 2 weeks x 3, then monthly x 3 (see V.l). Sites will be 
rotated as follows: right leg, left arm, right arm, left leg, depending on the 
presence of draining lymph nodes. Each injection site will be marked. 
3. There will be no dose reductions for toxicity. If grade 3/4 toxicity is 
observed (other than local grade 3 toxicity), the patient will be removed from 
the study. 
4. A surgical biopsy of one of the vaccination sites will be performed in 
consenting patients 2 weeks after the first and fourth injections. Sampling 
(removal) of a superficial lymph node (if enlarged secondary to vaccination) 
is planned 2 weeks after the first and fourth injections. 
5. Tumor measurements are obtained just prior to the 4th injection, then every 
other month. Treatment should continue as long as patients are found to have 
stable disease or evidence of an objective response. A maximum of 6 vaccine 
injections is allowed. Patients with slowly progressive disease (as determined 
by the treating physician) on their first evaluation (prior to the fourth 
injection) may continue treatment. Patients with rapidly progressive disease 
noted at any time during the study period should be taken off study. Every 
effort will be made to put patients with progressive disease on a new BRMP 
protocol containing systemic administration of 
IL-2 . 
6. Supportive Care = Concurrent treatment with steroids, other anti-neoplastic 
therapy, colony-stimulating factors or other investigational drugs is 
[734] 
Recombinant DNA Research, Volume 18 
