Table 1.

Summary of subject characteristics, toxicity, and immunogenicity

UPNCohort no./(μg/kg/dose)AgeDiagnosisToxicity (possibly, probably, or definitely related), maximum toxicity grade and type (grade)Anti-IL7 antibody titer
011/(3)70Renal cell carcinoma*1IS (1); EO (1)Positive (1/1,600)0
0248Hemangiopericytoma2ALT (2)Negative (0)NA
0367MelanomaNegative (0)NA
042/(10)56Melanoma2IS (2); CS (1)Negative (1/100)0
0571Renal cell carcinoma2IS (2); CS (1); ALT (1)Negative (0)NA
0628Carcinoma of unknown primary2IS (2); CS (2)Negative (0)NA
073/(30)21Osteogenic sarcoma3AST, bili (3); CS (1)NANA
0820Rhabdomyosarcoma1IS (1); CS (1)Positive (1/400)0
0928Synovial cell sarcoma1IS (1); CS (1); SM (1)Negative (1/100)0
1048Duodenal carcinoma2IS (2); CS (1)Negative (1/100)0
1161Colon carcinomaPositive (1/1,200)0
1262Melanoma2IS (2); CS, SOB (2); ALT, bili (1)Positive (1/400)0
134/(60)19Melanoma2IS (2); CS, bili (2); ALT, AP, Plt (1)Positive (1/1,200)0
1435Pheochromocytoma3Cardiac§ (3); AST, ALT (1)Negative (1/100)NA
1543Ovarian carcinoma3ALT (3); AST, IS (2); CS, AP (1)Positive (1/1,200)0
1666Melanoma1IS, CS, bili (1)Negative (0)NA

Abbreviations: ALT and AST, transaminases; AP, alkaline phosphatase; bili, total bilirubin; CS, constitutional symptoms; EO, eosinophilia; IS, injection site; erythema, induration, pruritus; Plt, decreased platelets; SM, splenomegaly; SOB, shortness of breath.

  • *Received initial lot of “CYT 99 007.”

  • Received only one dose.

  • Received only three doses.

  • §See text.