7.2 After Therapy: 
A. Physical examination 1, 2, 4, and 7 days after each vaccination that 
will include an assessment of the vaccination sites. 
B. Weekly blood tests (x 4) including: 
1 . 
CBC with differential 
and platelet counts 
2. 
Chemistries (see 
above ) 
3. 
PT , PTT 
4. 
Serum (10ml) and 
PBMC 
(30ml) for storage 
C. Biopsy of vaccination sites on days 14, 15, 16, 18, and 21. 
8.0 CRITERIA FOR RESPONSE 
Patients will be assessed at one and two months following their second 
vaccination for evidence of tumor response using physical examination or 
radiographic studies. Responses will be defined as follows: 
A. Complete response- disappearance of all measurable disease for at least 
1 month without the development of new lesions. 
B. Partial response- 502 or greater decrease in the sum of the products 
of the perpendicular diameters of all measurable lesions lasting at 
least 4 weeks with no increase in the size of existing lesions or 
appearance of new lesions. 
C. No response- any patient not manifesting a complete or partial 
response . 
9.0 REPORTING OF ADVERSE REACTIONS 
All side effects will be graded using the standard toxicity sheet used in prior 
immunotherapy protocols presented in appendix 18.7. Adverse reactions will be 
reported promptly to the Investigational Drug Branch at (301) 496-7957. Reports 
are required even if there is only a suspicion of an adverse effect. Previously 
unknown grade 2 and grade 3 reactions will be reported to the NCI in writing 
using the "NCI Adverse Reactions Form for Investigational Agents" within 10 
working days. Grade 4 (life-threatening) reactions and patient deaths while on 
treatment will be reported to NCI by phone within 24 hours. A written report 
will follow within 10 working days. Written reports will be sent to: 
Investigational Drug Branch 
Cancer Therapy Evaluation Program 
P.0. Box 30012 
Bethesda, Maryland 20824 
[508] 
Recombinant DNA Research, Volume 16 
