9.0 EVALUATION OF RESPONSE/ENDPOINTS 
9.1 Toxicity 
Toxicity is described in 6. 1 and Appendix II. The MTD (maximum tolerated dose) is 
defined as that dosage level immediately below the dosage level at which 2 patients of 
a cohort experience dose-limiting toxicity. 
9.2 Clinical Response 
Patients with measurable disease will have serial measurement of such indicator lesions 
which will be considered for response according to the definitions below, at 6 weeks, and 
thereafter. 
9.2.1 Complete Response ICRL Total disappearance of all measurable disease, M-l 
marrow status with restoration of normal hematopoiesis and normal performance 
status persisting at least 4 weeks. Onset of response will be appropriately noted 
and detailed, and duration noted. 
9.2.2 Very Good Partial Response (VGPR) : Regression of primary tumor (>90%), 
clearing metastatic disease except for persistent bone scan positive lesions attained 
by and maintained through induction. 
9.2.3 Partial Response (PR) : Regression of >50% of all tumor. 
9.2.4 Stable Disease: Exists when a patient fails to qualify for either complete response, 
VGPR, partial response or progressive disease. 
9.2.5 Progressive Disease: Worsening of disease, evidenced by enlargement of existing 
tumors or appearance of new disease. 
9.3 Immunological End-Points 
The principal evaluable goals of this phase I trial are largely immunological and include 
skin tests, evaluation of lymphocyte cytotoxicity, measurement of plasma cytokine levels 
and immunohistochemical analysis of tumor biopsies. 
9.3.1 Skin tests 
Patients will be skin tested with an intradermal injection of irradiated (5,000 c 
Gy), cryopreserved autologous tumor. The skin test will be given prior to 
treatment and at monthly intervals after treatment initiation. The skin test dose 
will be 5X10 5 cryopreserved cells in 0.05 ml normal saline injection 
intradermally. Erythema and induration will be measured in millimeters 24 and 
48 hr after injection. The skin test site will be on either arm. 
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