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Study on AloCelyvir with Chemotherapy and Radiotherapy for Children and Adolescents with Relapsed or Refractory Extracranial Solid 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 and adolescents who have relapsed or refractory extracranial solid tumors. These are types of cancer that occur outside the brain and have either returned after treatment or have not responded to standard treatments. The study will use a treatment called AloCelyvir, which is a special type of cell therapy. AloCelyvir is made from allogenic bone marrow-derived mesenchymal stem cells that have been modified with a virus called ICOVIR-5. This treatment will be combined with standard cancer treatments like chemotherapy and radiotherapy.

The purpose of the study is to evaluate the safety of adding AloCelyvir to the existing treatment plan for these tumors. Participants in the study will receive the combination of AloCelyvir, chemotherapy, and radiotherapy. The study will monitor how well patients tolerate the treatment and any side effects they may experience. The trial will also look at how effective the treatment is in reducing the size of the tumors and improving the patients' overall health.

Throughout the study, researchers will carefully observe the participants to ensure their safety and to gather information on how the treatment affects the tumors. The study aims to find the best dose of AloCelyvir that can be safely used with chemotherapy and radiotherapy. This research is important for developing new treatment options for young patients with these challenging types of cancer.

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 trial
Upon joining the trial, the patient will receive detailed information about the study and will be asked to provide written consent. This consent confirms understanding and agreement to participate in the trial.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes checking the patient's age, medical condition, and overall health status. The patient must have a relapsed or refractory extracranial solid tumor and meet other health criteria.
Step 3
Treatment plan
A treatment plan will be developed, which includes the combination of AloCelyvir with chemotherapy and radiotherapy. The plan will be tailored to the patient's specific condition and needs.
Step 4
Administration of AloCelyvir
AloCelyvir is administered as a cell suspension for injection through intravenous perfusion. The exact dosage and frequency will be determined by the medical team based on the patient's response and tolerance.
Step 5
Monitoring and follow-up
The patient will be closely monitored throughout the trial. Regular visits will be scheduled to assess the patient's response to the treatment and to check for any side effects. Adjustments to the treatment plan may be made as necessary.
Step 6
Completion of trial
Upon completion of the trial, the patient's overall health and response to the treatment will be evaluated. The patient will receive information about any further steps or follow-up care needed.

Who can join the trial?

11 criteria

Patients aged between 1 year and 21 years.
Written informed consent is required. This means you agree to participate after understanding the study details.
Must have a break period from previous treatments.
Patients with extra-cranial solid tumors that have come back or do not respond to treatment, and for which there is no standard cure.
The disease must be measurable or evaluable according to RECIST criteria v1.1, which is a standard way to measure how well a tumor responds to treatment.
The combination of chemotherapy and radiotherapy must be suitable for the patient. Patients may have received these treatments before.
Must have adequate functional status, meaning the patient is well enough to participate, with proper kidney, liver, and blood function.
Patient must be able to follow the treatment plan and attend scheduled visits and evaluations.
Life expectancy must be at least 3 months.
Sexually active men and women of childbearing age must use appropriate contraceptive methods to prevent pregnancy.
Women of childbearing age must have a negative pregnancy test.

Who cannot join the trial?

9 criteria

Patients who have not been diagnosed with relapsed or refractory extracranial solid tumors in children and adolescents cannot participate. This means the study is only for those whose cancer has returned or did not respond to treatment and is located outside the brain.
Patients who are not within the specified age range cannot participate. The study is for children and adolescents.
Patients who are not able to follow the study procedures or do not agree to participate cannot join the study.
Patients who have other medical conditions that might interfere with the study treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have had a recent major surgery or injury that has not healed cannot participate.
Patients who have an active infection or other serious illness cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.

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Verified sites

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Hospital Vall d’Hebron
Verified
Barcelona, Spain

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Investigated drugs

AloCelyvir
is an experimental treatment being tested in this clinical trial. It is designed to work alongside other cancer treatments to help fight tumors that have come back or are not responding to standard treatments. AloCelyvir is used in combination with chemotherapy, surgery, and radiotherapy to see if it can improve the effectiveness of these treatments in children and adolescents with certain types of solid tumors outside the brain.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this trial, chemotherapy is part of a combination treatment plan to help reduce the size of the tumors and make them easier to remove or treat with other methods.
Radiotherapy
is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. It targets specific areas of the body where the cancer is located. In this trial, radiotherapy is used alongside other treatments to help control the growth of the tumors and improve the chances of successful treatment.

Allogenic Bone Marrow-Derived Mesenchymal Stem Cells Transduced With Icovir-5, Ex Vivo Expanded

What is already known about the treatment

AloCelyvir – AloCelyvir is administered as part of a combination treatment that includes chemotherapy and radiotherapy, specifically for children and adolescents with relapsed or hard-to-treat solid tumors outside the brain. Currently, it is being studied in clinical trials to confirm its safety when used with other cancer treatments. The main goal is to help treat these challenging tumors by enhancing the effects of standard cancer therapies. AloCelyvir works at the molecular level by targeting cancer cells, although the exact mechanism is still under investigation. It falls under the category of experimental cancer therapies, as it is not yet widely used in standard medical practice.

Investigated diseases

Relapsed or refractory extracranial solid tumors in children and adolescents – These are solid tumors located outside the brain that have either returned after treatment (relapsed) or have not responded to treatment (refractory) in children and adolescents. These tumors can occur in various parts of the body, such as the abdomen, chest, or limbs. The progression of these tumors can vary depending on the type and location, but they generally grow by invading surrounding tissues and can spread to other parts of the body. As they progress, they may cause symptoms related to the affected area, such as pain, swelling, or dysfunction of nearby organs. The growth rate and behavior of these tumors can differ significantly, making each case unique.