A Phase 1 trial of autologous monocytes stimulated ex vivo with Sylatron® (Peginterferon alfa-2b) and Actimmune® (Interferon gamma-1b) for intra-peritoneal administration in recurrent ovarian cancer

Table 1 Time line of line placement, monocyte isolation, stimulation with IFNs, and infusion

Dose level	Monocytes total number	SYLATRON^® peginterferon alfa2b, mcg	ACTIMMUNE ^® interferon gamma-1b, mcg
1	0	25	5
2	75 × 10⁶	25	5
3	750 x 10⁶	25	5
3b	0	250	50
4	750 x 10⁶	250	50

Using a standard 3 + 3 phase 1 clinical design patients in levels 1 and 3b will receive Sylatron^® (Peginterferon alfa-2b) and Actimmune^® (Interferon gamma-1b) at low dose and high dose respectively
Patients enrolled in levels 2, 3 and 4 will receive escalating doses of monocytes and Sylatron^® (Peginterferon alfa-2b) and Actimmune^® (Interferon gamma-1b), with monocyte number increasing before Sylatron^® (Peginterferon alfa-2b) and Actimmune^® (Interferon gamma-1b)

ISSN: 1479-5876