A team from Germany, Denmark, and Austria conducted a Phase I/II trial to assess the safety and feasibility of local activation of low-dose ifosfamide in patients with inoperable pancreatic carcinoma.
14 patients who were admitted to the Division of Gastroenterology, University of Rostock, Germany, were enrolled in the study. All had a histologically proven, measurable (computed tomography scan), and inoperable pancreatic adenocarcinoma Stage III-IV.
The researchers encapsulated genetically modified allogeneic cells, which expressed a cytochrome P450 enzyme, in cellulose sulphate. These were then delivered by supraselective angiography to the tumor vasculature. The modified allogeneic cells locally activated systemically administered ifosfamide.
The tumors of 4 patients were found to regress after treatment. Those of the other 10 individuals who completed the study remained stable.
12 cases of serious adverse events were recorded; none of these were related to treatment. There was no evidence of pancreatitis or allergic response during the study.
|Median survival was doubled in patients receiving ifosfamide.|
A historic control group of patients with non-resectable pancreatic carcinoma was used as a comparison.
The researchers found that median survival was doubled in the treatment group, in comparison with historic controls. One-year survival rate was three times better.
Professor Matthias Löhr, of the University of Rostock, concluded on behalf of the group, "Further studies of this cell-therapy-based treatment combined with chemotherapy for inoperable pancreatic cancer are warranted."