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Study on the Effects of Rintatolimod After FOLFIRINOX in Patients with Locally Advanced Pancreatic Cancer

Verified siteInvestigationalNo 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 a type of cancer known as locally advanced pancreatic cancer. The treatment being tested in this study is called Ampligen, which is also known by its scientific name, rintatolimod. Ampligen is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. The purpose of the study is to compare the effectiveness and safety of Ampligen against a control group that receives no additional treatment after a standard chemotherapy regimen called FOLFIRINOX.

Participants in the study will have already completed at least four months of FOLFIRINOX treatment without their cancer progressing. The study will involve regular visits to monitor the participants' health and the progression of their cancer. The main goal is to see how long participants can live without their cancer getting worse, which is referred to as Progression Free Survival (PFS). This will be measured from the time of the first treatment with Ampligen until the cancer progresses, the participant passes away, or the study ends.

The study is designed to last for several years, with an estimated completion date in 2028. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of Ampligen in treating locally advanced pancreatic cancer. This research aims to provide valuable insights into potential new treatment options for this challenging condition.

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
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups: one group will receive the medication Ampligen, and the other group will not receive any treatment. This is to compare the effects of the medication against no treatment.
Step 2
First treatment visit
If you are in the group receiving Ampligen, you will start your treatment with an intravenous infusion. This means the medication will be given to you through a vein. The dosage and frequency of the medication will be determined by the study team.
Step 3
Ongoing treatment
You will continue to receive the Ampligen infusions as scheduled by the study team. The duration of the treatment will depend on your response to the medication and the overall study plan.
Step 4
Regular monitoring
Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This may include physical exams, blood tests, and imaging tests like CT or MRI scans.
Step 5
End of study
The study will continue until there is a clear understanding of the medication's effects, or until the study's planned end date. You will be informed about the results and any next steps regarding your treatment.

Who can join the trial?

20 criteria

Must have a confirmed diagnosis of locally advanced pancreatic cancer that cannot be removed by surgery.
Must have a disease that can be measured using specific medical guidelines.
Must have completed at least four months of a specific chemotherapy treatment called FOLFIRINOX and show no disease progression in scans taken 4 to 12 weeks after the last treatment.
Must be 18 years or older.
If female, must not be pregnant or breastfeeding and must have a negative pregnancy test. Must agree to use birth control during the study and for 90 days after the last treatment.
If male, must agree to use a condom during the study and for 90 days after the last treatment. Must not donate sperm during this time.
Must provide signed consent to participate and be willing and able to follow study requirements.
Must weigh at least 40 kg (about 88 pounds).
Must have a Karnofsky Performance Status of 80 or higher, which means being able to carry out normal activities with some effort.
Must have a life expectancy of at least 3 months according to the study doctor.
Must have adequate organ function as shown by specific blood tests, including:
- Platelets (a type of blood cell) of at least 100,000 per microliter.
- Hemoglobin (a protein in red blood cells) of at least 9.0 g/dL.
- Absolute Neutrophil Count (a type of white blood cell) of at least 1,500 per microliter.
- Absolute lymphocyte count of at least 3,000 per microliter.
- Liver enzymes (AST/ALT) within specific limits, depending on liver condition.
- Alkaline phosphatase within specific limits, depending on liver condition.
- Total bilirubin within specific limits.
- Albumin (a protein in the blood) of at least 3.0 g/dL.
- Creatinine clearance (a measure of kidney function) of at least 60 mL/min.
- Normal blood clotting tests (PT-INR and APTT).

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with locally advanced pancreatic cancer cannot participate.
Patients who have not received the treatment called FOLFIRINOX cannot participate. FOLFIRINOX is a combination of drugs used to treat pancreatic cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands

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Investigated drugs

Ampligen® is a medication being studied for its potential to help treat pancreatic cancer. In this trial, researchers are looking at how well Ampligen® works in people who have a specific type of pancreatic cancer called locally advanced pancreatic adenocarcinoma. The goal is to see if Ampligen® can improve outcomes for patients who have already received a standard chemotherapy treatment known as FOLFIRINOX. Ampligen® is thought to work by boosting the body's immune system to help fight cancer cells.

Rintatolimod

What is already known about the treatment

Ampligen – Ampligen is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its potential use in treating locally advanced pancreatic cancer, particularly after patients have undergone a chemotherapy regimen known as FOLFIRINOX. The main therapeutic indication for Ampligen in this context is to improve outcomes for patients with this type of cancer. At the molecular level, Ampligen works by stimulating the immune system to better recognize and attack cancer cells. It is classified as an immunomodulatory drug, which means it helps modify the immune response.

Investigated diseases

Locally Advanced Pancreatic Adenocarcinoma – This is a type of cancer that originates in the tissues of the pancreas, which is an organ located behind the lower part of the stomach. In its locally advanced stage, the cancer has spread to nearby tissues or organs but has not metastasized to distant parts of the body. The disease often progresses by invading surrounding structures such as blood vessels, making surgical removal challenging. As the cancer grows, it can cause symptoms like abdominal pain, weight loss, and jaundice. The progression of the disease can lead to further complications, including obstruction of the bile duct or intestines. The growth and spread of the tumor are typically monitored through imaging studies and clinical evaluations.