Serum IL-4 assays will be performed prior to tumor vaccination, at the time of LN 
harvest, at the time of adoptive cellular therapy; and at 1 and 2 months after completion of 
therapy. 
9.0 CRITERIA FOR EVALUATION/REMOVAL FROM STUDY/RETREATMENT 
Definition of responses: to be determined after a minimum of 4 weeks. 
9.1 Complete tumor response (CR) is defined as disappearance of all signs, 
symptoms, biochemical, and radiographic evidence of tumor. In the case of 
accessible cutaneous or subcutaneous metastases, tissue biopsy of at least 
one known site of tumor is requested. 
9.2 Partial response (PR) is defined as a reduction of all measurable tumor lesions 
by 50% of the product of the two greatest perpendicular diameters (sum of all 
evaluable tumors), without the appearance of new tumor lesions or the 
concurrent progression of any previously defined lesions. 
9.3 Minimal response (MR) is defined as a reduction of all measurable tumor 
lesions by > 25% but < 50% of the product of the two greatest perpendicular 
diameters (sum of all evaluable tumors), without the appearance of new lesions 
or the concurrent progression at any sites of known disease. 
9.4 Stable disease (SD) includes all with response less than described for 
progressive disease. 
9.5 Progressive disease (PD) is defined as an increase of all measurable tumor 
lesions by > 25% of the product of the two greatest perpendicular diameters 
(sum of all evaluable tumors), or the appearance of new lesions. 
9.6 Patients that recur at any site will be considered as failures of that treatment and 
other standard or experimental treatments will be considered as appropriate for 
their disease. If a tumor response (PR or CR) is evident by 2 months post 
treatment, then retreatment with activated cells from cryopreserved material 
during the following month will be offered to the patent. If cryopreserved LN are 
not available, then retreatment with IL-2 alone will be offerred. 
10.0 STATISTICAL CONSIDERATIONS 
Fifteen patients will be enrolled into this study. This has been deemed adequate to 
determine several in vitro and in vivo immunologic parameters which are being followed. 
Cytotoxicity, proliferation and cytokine release (ie. TNF or IFNy) to autologous tumor will be 
measured of the vaccine-primed LN in vitro. Evidence of tumor-specific responses in these 
assays would be a basis for a phase II study since an antitumor effect may be related to the 
quantitative requirement of larger numbers of adoptively transferred cells. Similarly, if there 
is evidence for the development of cutaneous hypersensitivity to autologous tumor after 
adoptive immunotherapy in the majority of patients, then a phase II study is justified. Any 
objective tumor response in this study (PR or CR) will justify a phase II study. 
11.0 ETHICAL & REGULATORY CONSIDERATIONS 
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