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HDC is administrated in combination with IL-2 as peri- and post-operative treatment in patients undergoing surgery. 0.5 mg HDC is administered twice daily by subcutaneous injections 1 to 3 minutes after each IL-2 injection during three 3 week cycles, with 3-week resting periods inbetween. The first treatment cycle is initated 2 weeks prior to surgery, with an additional 2-3 days rest period during the surgical procedure, before the third treatment week is initiated.

Histamine Dihydrochloride (HDC)

IL-2 is administrated in combination with HDC during three 3 week cycles as peri- and post-operative treatment in patients undergoing surgery. IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of histamine dihydrochloride; each dose of IL-2 is 16,400 IU/kg (1µg/kg).

Interleukin-2 (IL-2)

Svein Olav Bratlie

Andreas Muth

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.

This is a single center, open-label study in subjects with resectable pancreatic cancer. Eligible subjects will be offered treatment with histamine dihydrochloride and low-dose interleukin-2. Secondary endpoints comparing matched historical controls (DFS, OS).

Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer

A Phase I/II Trial of Peri- and Postoperative Treatment With Histamine Dihydrochloride and Low-dose Interleukin-2 in Patients With Primary Resectable Pancreatic Cancer

Incidence and severity grade of adverse events occuring during and after treatment will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.

Comparing matched historical controls from national registry

Changes in NK cell number and expression of activation markers during surgery

Changes in T cell number and expression of activation markers during surgery

Changes in myeloid cell number and markers of activation and inhibition

Tumor pieces removed during surgery will be assessed for immune populations

Serum CA 19-9 levels are monitored as a biomarker for disease recurrance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer	NCT05810792	Pancreatic Canc... Surgery Metastasis Immunosuppressi...	Histamine Dihyd... Interleukin-2 (...	18 Years -	Sahlgrenska University Hospital, Sweden
Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer	NCT05810792	Pancreatic Canc... Surgery Metastasis Immunosuppressi...	Histamine Dihyd... Interleukin-2 (...	18 Years -	Sahlgrenska University Hospital, Sweden

Spots Global Cancer Trial Database for histamine dihydrochloride (hdc)