AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Feasibility clinical trial of the combination of AloCelyvir with chemotherapy and radiotherapy for the treatment of children and adolescents with relapsed or refractory extracranial solid tumors.

This research is a trial for young people aged 18 and older who have a type of cancer that affects parts of the body other than the brain or spine. This cancer has either returned after treatment or hasn't responded to previous treatments. The study is investigating a new treatment called AloCelyvir, which will be given alongside standard chemotherapy and radiotherapy. The main goal of this early-stage study is to work out the safest dose of this new combination. Researchers will closely watch for any side effects. They will also look at how well the treatment shrinks the cancer and how long patients live after treatment.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Enrolment target

Start

10 Oct 2024

Relapsed or refractory extracranial solid tumors in children and adolescents.

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test new treatments in people. It focuses on young people, aged 18 and over, who have a type of cancer that is not in the brain or spine. This cancer has either come back after treatment or hasn't improved with standard treatments.

The main aim of this first part of the study is to find the safest amount, or 'dose', of a new treatment called AloCelyvir when it's given together with chemotherapy and radiotherapy. Researchers will be carefully monitoring participants for any side effects to make sure the dose is safe. They also want to see if it's practical to give this new combination treatment and how quickly it can be prepared and given to patients once they join the study.

After they find the safest dose, the study will also look at how well this new combination treatment works. This includes checking if the treatment helps to shrink the cancer and how long patients live and remain free from cancer growth. They will also keep track of any side effects, often called 'adverse events', to fully understand the treatment's safety profile.

Key takeaways

This study explores a new treatment for young people (18+) with specific cancers outside the brain.
It combines a new drug (AloCelyvir) with standard chemotherapy and radiotherapy.
The initial goal is to find the safest dose of the new combined treatment.
It's for cancers that have come back or not responded to previous treatments.
Researchers will also look at how well the treatment works and any side effects.
This is an early-stage study (Phase I) focused on safety.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There is no upper age limit for taking part.

This study is for young people who have cancer that started outside of the brain or spine. Importantly, your cancer must have either come back after you’ve had treatment before, or it hasn't responded well to the treatments you've already received.

Both males and females can take part in this research. The study will have other specific medical rules about who can join, which will be discussed with you by the study doctor to make sure it's the right fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Do I have cancer that is outside of my brain or spine?
Has my cancer come back after treatment, or has it not responded to my previous treatments?
Am I a male or a female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new treatment called AloCelyvir along with standard chemotherapy and radiotherapy, as decided by the study doctors. The study will be divided into two main parts. The first part is about finding the safest dose of the combination treatment. During this time, the doctors will gradually increase the dose of AloCelyvir in different groups of patients while closely watching for side effects.

You will have regular hospital visits for your treatments and to assess your health. These visits will involve various tests, such as blood tests, scans, and physical examinations, to check how you are responding to the treatment and to monitor for any side effects. The total length of your participation will depend on how you respond to the treatment and the study's follow-up plan, but you will be kept fully informed about this.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment combination that is not yet widely available, and which might help to control your cancer. However, as with any new treatment, there are potential risks of side effects from AloCelyvir, as well as from the chemotherapy and radiotherapy. The research team will carefully monitor you for any side effects and manage them as best they can. It is very important to remember that participating in a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is AloCelyvir?

AloCelyvir is a new treatment being tested in this study. The researchers are giving it alongside standard chemotherapy and radiotherapy for certain types of cancer.

What does 'relapsed or refractory' mean?

'Relapsed' means your cancer has returned after you've had treatment. 'Refractory' means your cancer hasn't responded to treatments you've tried before.

Why is this only for people aged 18 and older?

This particular study is designed for adults aged 18 and above. Different studies might be available for younger age groups.

What does 'extracranial solid tumors' mean?

This refers to cancers that are solid, meaning they form a lump, and are located in places other than the brain or spinal cord.

Will I definitely get the new treatment if I join?

If you are eligible and choose to join, you will receive AloCelyvir as part of the combination treatment, as this study is testing its safety and effectiveness.