Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer
Status:
Not yet recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
A key aspect of the trial is that functions of anti-neoplastic T cells and natural killer
(NK) cells, may be inhibited by immunosuppressive signals from myeloid cells, in particular
reactive oxygen species (ROS) produced by several subsets of myeloid cells. In cancer, such
immunosuppressive cells are commonly denoted myeloid-derived suppressor cells (MDSCs), which
are immature monocytes and granulocytes that impede immune-mediated clearance of malignant
cells by multiple mechanisms, including the formation of immunosuppressive ROS via myeloid
cell NADPH oxidase (NOX2). The presence of MDSCs within or adjacent to tumor tissue is
assumed to facilitate the growth and spread of tumors and may also dampen the efficacy of
cancer immunotherapies. The underlying hypothesis for this clinical trial is the
administration of HDC/IL-2 will reduce surgery-induced inflammation and reduce metastasis. A
phase I/II open label, single-center study of the safety, tolerability, and efficacy of peri-
and postoperative therapy with histamine dihydrochloride and low-dose interleukin-2 treatment
in subjects with primary pancreatic cancer.To assess the frequency and extent of adverse
events associated with low dose interleukin-2 and histamine dihydrochloride when used as
perioperative therapy.To determine progression free survival and overall survival following
surgery, and compare with matched historical controls from the Swedish Cancer Registry.