- Antitumor activity and overall tolerability were demonstrated in phase 1 study of interferon activated autologous monocytes infused intraperitoneally in patients with heavily pretreated, platinum-resistant or refractory ovarian cancer.
Why this matters
- Applying immune system-modulating therapies directly to the tumor in the peritoneum may provide a new avenue of treating late-stage ovarian cancer.
- 18 patients (median age, 61 years; median 5 prior therapies) with platinum-resistant or refractory metastatic or unresectable ovarian cancer were enrolled in 4 cohorts treated every 28 days with peginterferon alfa-2b and interferon gamma-1b.
- 15 patients in 3 cohorts received 1 of 3 dose levels of autologous monocytes.
- The primary objective was to determine the safety and identify the maximum tolerated dose (MTD).
- Funding: US National Institutes of Health.
- The highest dose was the MTD – 250 µg peginterferon alfa-2b, 50 µg interferon gamma-1b, and 750x106 autologous monocytes.
- 2 of 11 evaluable patients had partial responses, 6 had stable disease, and 3 showed disease progression.
- Toxicities included fatigue, nausea, and abdominal pain with none grade ≥4.
- Small, early-phase study, with open-label design.
Dr Christopher Browning Cole, of the National Cancer Institute in Bethesda MD, who presented these results, commented: “This has led to a lot of interest in directing therapies directly to the tumor in the peritoneum...and many of these trials have shown some really impressive results in terms of [overall survival] advantage in long-term follow-up.”