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

From: 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

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
  1. 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
  2. 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)