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2024-04-01
2027-04-01
2028-04-01
50
NCT05810792
Sahlgrenska University Hospital
Sahlgrenska University Hospital
INTERVENTIONAL
Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-03-07 | N/A | 2023-11-20 |
2023-03-31 | N/A | 2023-11-22 |
2023-04-12 | N/A | 2023-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Patients receiving immunomodulating treatment | DRUG: Histamine Dihydrochloride (HDC)
DRUG: Interleukin-2 (IL-2)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence and severity of Treatment-Emergent Adverse Events as assessed by NCI-CTCAE | 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. | When the first 14 patients have undergone one full 3-week cycle with HDC/IL-2 (approximately 18 months after trial start) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | Comparing matched historical controls from national registry | 24 months |
| Disease free survival | Comparing matched historical controls from national registry | 24 months |
| Changes in Natural killer cell subsets in blood | Changes in NK cell number and expression of activation markers during surgery | Change from pre-surgical levels to levels during the post-surgical week |
| Changes in T cell subsets in blood | Changes in T cell number and expression of activation markers during surgery | Change from pre-surgical levels to levels during the post-surgical week |
| Changes in Myeloid cell populations | Changes in myeloid cell number and markers of activation and inhibition | Change from pre-surgical levels to levels during the post-surgical week |
| Tumor infiltrating lymphocytes and tumor infiltrating myeloid cells | Tumor pieces removed during surgery will be assessed for immune populations | immediately after the surgery |
| Carbohydrate antigen 19-9 | Serum CA 19-9 levels are monitored as a biomarker for disease recurrance | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Svein Olav Bratlie Phone Number: +46313428218 Email: svein.olav.bratlie@vgregion.se |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
