Table 1.

Patient characteristics

Patient (Gender/Age)	Stage at Treatment	Previous Intravesical Treatments	Status At 3 Months	Current Status	Current Status Follow Up (months)
DOSE LEVEL 1
1 (M/60)	C1S	Thiotepa, BCG, BCG/IFN	CR	TaHG at 8.8mo, Cystectomy at 9.8mo, Currently NED	55.5
2 (M/57)	Ta HG, CIS	BCG × 3	Ta LG	Ta LG at 3.1mo, BCG+INF for 3yrs, Currently NED	61.6
3 (M/78)	Ta LG	BGG, BCG/IFN	Ta LG.	Ta LG at 3.1mo, Cystectomy at 3.6mo, Currently NED	51.8
DOSE LEVEL 2
4 (M/72)	CIS	BCG, BCG/IFN/Proleukin × 2	CR	CIS at 53.2mo, Cystectomy at 55.8mo, Currently NED	58.0
5 (F/56)	Ta HG, CIS	BCG × 2	Ta LG	Ta HG at 3.4mo, Cystectomy at 4.8mo, Currently NED	49.1
6 (M/78)	Ta HG, CIS	BCG × 2	CIS	T1 HG at 9.6mo, Cystectomy at 9.8mo, Currently NED	55.6
DOSE LEVEL 3
7 (M/38)	Ta HG	BCG, BCG/IFN	CR	DOC* w/o any TCC	31.3
8 (M/67)	CIS	BCG, BCG/IFN	CR	CIS at 20.9mo, Cystectomy at 23.5mo, Currently NED	50.5
9 (M/81)	CIS	BCG, BCG/IFN	T1HG	T1HG at 3.0mo, Cystectomy at 5.1mo, Died of Metastatic disease at 24.8mo	24.8
DOSE LEVEL 4
10 (M/65)	Ta HG	MVAC, BCG, BCG/IFN, Mitomycin, Thiotepa	CR	Ta LG at 11.9mo treated with TURBT and Mitomycin, currently NED	41.9
11 (M/85)	Ta HG, CIS*	BCG × 3	Ta HG	Ta HG at 3.3mo, refused cystectomy, currently AWD	39.8
12 (M/77)	CIS	BCG × 3	CR	CR	29.0
13 (M/79)	Ta HG	BCG, BCG/INF, Gemcitabine + Mitomycin, Adriamycin + Docetaxel	CIS	CIS at 3mo, BCG/INF + Proleukin + GMCSF, Left upper tract recurrence and left nephroureterectomy at 12mo, progression at 17mo, Died of metastatic disease at 18.5mo	18.5
DOSE LEVEL 5
14 (M/78)	Ta HG	BCG × 2	CR	CR	39.2
15 (M/63)	CIS	BCG, BCG + IFN × 2	CIS	CIS at 3.0mo, Cystectomy at 4.5mo, Currently NED	32.6
16 (M/79)	Ta LG	BCG × 3	Ta LG	Ta LG at 3.2mo, Cystectomy at 15.5mo, Currently AWD (urethral recurrently Ta LG)	30.7
17 (M/55)	T1 HG, CIS#	BCG	Ta HG	Ta HG at 3.3mo, Cystectomy 8.5, Currently NED	28.5