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Study on the Effects of Histamine Dihydrochloride and Aldesleukin in Patients with Resectable Pancreatic Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying pancreatic cancer, a type of cancer that begins in the tissues of the pancreas, an organ in the abdomen that lies behind the lower part of the stomach. The study will explore the effects of a treatment involving two medications: aldesleukin and histamine dihydrochloride. Aldesleukin is a protein that helps boost the immune system, while histamine dihydrochloride is a chemical that can also support immune function. These medications will be given as injections.

The purpose of this study is to understand how often and how severe any side effects might be when using this treatment. Participants in the study will receive the medications around the time of their surgery for pancreatic cancer. The study will monitor participants from the start of the treatment until the final visit to see how their bodies react to the medications.

Throughout the study, researchers will keep track of any side effects that occur, whether they are related to the treatment or not. They will also look at how long participants live without the cancer getting worse and overall survival rates. Additionally, the study will examine various immune cells and markers in the blood to understand how the treatment affects the immune system. This information will help determine the safety and potential benefits of using aldesleukin and histamine dihydrochloride in treating pancreatic cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of two medications: aldesleukin and histamine dihydrochloride.
Aldesleukin is provided as PROLEUKIN®, a powder for solution for injection or infusion, and is administered subcutaneously.
Histamine dihydrochloride is provided as Ceplene, a solution for injection, and is also administered subcutaneously.
Step 2
Treatment schedule
The treatment involves peri- and postoperative administration, meaning it occurs around the time of surgery.
The specific dosage, frequency, and duration of administration are determined by the study protocol and the healthcare team overseeing the trial.
Step 3
Monitoring and assessment
Throughout the trial, the safety and tolerability of the treatment are closely monitored.
Adverse events, which are any unwanted effects of the treatment, are recorded from the first day of the treatment cycle until the final study visit.
These events are graded for severity using a standardized system.
Step 4
Evaluation of treatment effects
The primary goal is to assess the frequency and extent of any adverse events associated with the therapy.
Secondary evaluations include measuring progression-free survival and overall survival, as well as analyzing various biomarkers in the blood and tumor tissue.
Step 5
Completion of trial
The trial is expected to continue until January 1, 2029, with recruitment starting on April 1, 2024.
Upon completion, the data collected will contribute to understanding the safety and effectiveness of the treatment for pancreatic cancer.

Who can join the trial?

4 criteria

Patients must provide written informed consent before starting the therapy. This means they agree to participate after understanding the study details.
Patients can be male or female and must be older than 18 years.
The patient must be considered fit for pancreatic surgery by the surgeon. This means the surgeon believes the patient is healthy enough to undergo the surgery.
Patients must have confirmation of pancreatic or periampullary cancer through imaging tests or cell samples. This includes common types like pancreatic ductal adenocarcinoma, ampullary carcinoma, and cholangiocarcinoma, as well as other rare forms of these cancers.

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

Histamine Dihydrochloride
is used in this trial to help the immune system fight cancer. It works by protecting important immune cells from being damaged, allowing them to attack cancer cells more effectively.
Interleukin-2
is a medication that boosts the immune system. It helps increase the number of immune cells in the body, which can help in fighting cancer. In this trial, it is used in low doses to support the body's natural defenses against pancreatic cancer.

What is already known about the treatment

Histamine Dihydrochloride
This medication is administered through injection and is currently being studied in clinical trials for its potential use in treating pancreatic cancer. It is not yet widely used in standard medical practice, as research is ongoing to determine its safety and effectiveness. The main therapeutic indication is for patients with primary resectable pancreatic cancer. Histamine dihydrochloride works by modulating the immune response, potentially enhancing the body's ability to fight cancer cells. It is classified as an immunomodulatory agent.
Interleukin-2 (Low-Dose)
This medication is also administered via injection and is under investigation in clinical trials for its role in treating pancreatic cancer. It is not yet a standard treatment, as studies are assessing its safety and potential benefits. The primary therapeutic use is for patients with primary resectable pancreatic cancer. Interleukin-2 functions by stimulating the growth and activity of certain immune cells, which may help in attacking cancer cells. It is classified as a cytokine and immunotherapy agent.

Investigated diseases

Pancreatic cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. It often begins in the cells that produce digestive juices or hormones. As the cancer progresses, it can invade nearby organs and spread to other parts of the body. Symptoms may include jaundice, weight loss, and abdominal pain, but they often appear only in advanced stages. The disease can grow and spread quickly, making early detection challenging. It is typically classified based on the type of cell in which it begins, such as adenocarcinoma, which is the most common type.