Table 1.

Patient Demographics

Characteristic	N (%)
Dose Level
Phase I	6
Phase II	17
Sex
Male	18 (78)
Female	5 (22)
Age (Years)
Mean ± SD	58.8 ± 8.7
Median (Range)	57 (42–74)
Performance Status
0	14 (61)
1	9 (39)
Previous Nephrectomy	22 (96)
Previous Radiation Therapy	10 (43)
Previous Systemic Treatment*
None	7 (30)
Antiangiogenic only†	1 (4)
IL-2 and/or IFN-α only	3 (13)
IL-2 and/or IFN-α based	12 (52)
Chemotherapy	2 (9)
Antiangiogenic therapy†	7 (30)
Other	3 (13)
Histology
Clear cell	21 (91)
Papillary	1 (4)
Other	1 (4)
Diagnosis to On-Study (Months)
Median (Range)	27.5 (5.1 Months–19.3 Years)

^*Some patients were on > 1 type of anticancer therapy before the study.

^†Primarily thalidomide and lenalidomide.

Abbreviations: IFN = interferon; IL = interleukin; SD = standard deviation