Not recruitingRare disease

Study on Murcidencel for Children, Adolescents, and Young Adults with High-Risk Progressive or Recurrent Metastatic Tumors

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 treating children, adolescents, and young adults who have high-risk tumors that are either progressing, have come back after treatment, or have spread to other parts of the body. The treatment being studied is a special type of vaccine called the Autologous dendritic cell vaccine producing interleukin 12, also known by its code name murcidencel. This vaccine is made from the patient's own cells and is designed to help the immune system fight cancer by producing a substance called interleukin 12, which can boost the body's natural defenses.

The purpose of this study is to assess the safety of this vaccine when used in combination with other treatments for these high-risk cancers. Participants in the study will receive the vaccine through an injection under the skin, known as intradermal use. The study will monitor the participants for any special side effects that might occur, as well as track how the disease responds to the treatment over time.

Throughout the study, researchers will collect information on how long it takes for the cancer to progress, the overall survival of the participants, and the rate at which the cancer responds to the treatment. They will also keep track of any side effects, looking at their type, seriousness, and possible connection to the treatment. This information will help determine the safety and potential benefits of using the Autologous dendritic cell vaccine producing interleukin 12 in treating high-risk tumors in young patients.

The research process

The trial runs in 6 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, the patient must meet specific criteria, including age between 1 and 25 years and a confirmed diagnosis of a high-risk tumor.
The patient or their legal representative must sign an informed consent form.
Step 2
Preparation for treatment
Before treatment begins, the patient must have adequate organ function and must not have severe side effects from previous treatments.
Any previous therapies, such as chemotherapy or radiotherapy, must be completed at least three weeks before the start of the trial.
Step 3
Tumor tissue sampling
A surgical procedure is performed to collect tumor tissue. This tissue is used to create the autologous dendritic cell vaccine.
Step 4
Vaccine administration
The autologous dendritic cell vaccine is administered through an injection into the skin (intradermal use).
The vaccine is designed to produce interleukin-12, a substance that may help the immune system fight cancer.
Step 5
Monitoring and follow-up
The patient is monitored for any adverse events, which are side effects that may occur during the trial.
The primary goal is to assess the safety of the vaccine by analyzing the frequency of these adverse events.
Step 6
Evaluation of outcomes
Secondary outcomes include measuring the time until the disease progresses, overall survival, and the response rate to the treatment.
The clinical benefit rate and the frequency of all adverse events are also assessed.

Who can join the trial?

18 criteria

Age between 1 and 25 years.
The patient or their legal representative must sign a form agreeing to participate in the study.
The patient must have a confirmed diagnosis of a high-risk solid tumor that is not responding to treatment, has come back, or has spread to other parts of the body. This type of disease is considered high-risk if the chance of surviving for 5 years is less than 25% with standard treatments.
The patient must have a certain level of physical ability, measured by a score called the Karnofsky or Lansky score, which should be 50 or higher. This score helps determine how well the patient can perform daily activities.
The patient is expected to live for at least 10 more weeks.
Previous treatments:
- The patient should not have severe side effects (grade 3 or 4) from previous treatments like chemotherapy, surgery, or radiation.
- Any treatment that affects bone marrow should have been completed at least 3 weeks before collecting tumor tissue.
- Any targeted biological treatment should be stopped at least 7 days before collecting tumor tissue, or longer depending on the drug used.
- Any drugs that suppress the immune system should be stopped at least 3 weeks before collecting tumor tissue.
- Growth factors should be stopped at least 7 days before collecting tumor tissue.
- The patient should be able to have a surgical procedure to collect tumor tissue for making the vaccine.
- Radiation therapy should be stopped at least 3 weeks before collecting tumor tissue.
- If the patient had a transplant, it should be at least 3 months since an autologous transplant (using their own cells) or 6 months since an allogeneic transplant (using donor cells).
- Organ functions:
  - Bone marrow should be working well, with enough white blood cells, platelets, and hemoglobin without needing transfusions.
  - Kidneys should be working well, with a creatinine clearance rate of at least 70 mL/min/1.73 m² and serum creatinine within acceptable limits for the patient's age.
  - Liver should be working well, with bilirubin and liver enzymes (ALT and AST) within acceptable limits for the patient's age, even if there are liver metastases.
  - The heart should be working well, with certain measurements (fraction shortening and ejection fraction) showing good function.
  - Female patients who can have children must have a negative pregnancy test.

Who cannot join the trial?

10 criteria

Patients who do not have a type of cancer that is getting worse, coming back, or spreading to other parts of the body.
Patients who are not considered high-risk for their type of cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the specific combination therapy being tested.
Patients who have medical conditions that make it unsafe for them to participate in the study.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the components of the study treatment.
Patients who have certain infections or diseases that could interfere with the study.

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Verified sites

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Fakultni Nemocnice Brno
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Brno, Czechia

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Investigated drugs

Dendritic Cells Producing Interleukin-12 are a type of immune cell that has been modified outside the body to produce a substance called interleukin-12. This substance helps to boost the immune system's ability to fight cancer. In this trial, these cells are used as a vaccine to help treat children, adolescents, and young adults with high-risk tumors that are growing, have come back, or have spread to other parts of the body. The goal is to see if this treatment is safe and to monitor any special side effects that may occur.

Murcidencel

What is already known about the treatment

Dendritic Cell Vaccine with Interleukin-12 – This investigational therapy is administered as an autologous vaccine, meaning it is derived from the patient's own cells. It is currently being studied in clinical trials for its safety and effectiveness in treating high-risk pediatric cancers that are progressive, recurrent, or primarily metastatic. The main therapeutic indication is to enhance the immune response against cancer cells. The mechanism of action involves dendritic cells, which are a type of immune cell, being manipulated to produce interleukin-12, a protein that stimulates the immune system to attack cancer cells. This therapy falls under the pharmacological classification of immunotherapy, specifically as a cancer vaccine.

Investigated diseases

Progressive, recurrent or primarily metastatic high-risk pediatric malignancies – These are aggressive cancers that occur in children and are characterized by their tendency to grow rapidly, return after treatment, or spread to other parts of the body from the start. These malignancies can affect various organs and tissues, leading to a range of symptoms depending on the location and type of cancer. The progression of these cancers can be unpredictable, with periods of rapid growth and potential spread to distant sites. Recurrent malignancies are those that have returned after a period of remission, while primarily metastatic cancers have already spread at the time of diagnosis. The behavior of these cancers often requires close monitoring and can involve complex treatment strategies.