Active not recruitingPHASE1INTERVENTIONAL

A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

This study is looking at a new treatment called SurVaxM, which is a type of vaccine for certain brain tumours in children and young adults. Instead of preventing illness, this vaccine is designed to help your body's defence system (immune system) fight cancer. It works by teaching your immune system to recognise and attack tumour cells that carry a specific protein called survivin. This protein is often found on cancer cells but not healthy ones. The study involves giving this vaccine, combined with another ingredient to boost its effect, through injections under the skin over a period. Researchers will be carefully checking how safe the vaccine is and how well it works in different types of brain tumours like medulloblastoma and high-grade glioma.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Children's Oncology Group

Enrolment target

Start

01 Jul 2022

Estimated completion

31 Dec 2027

Medulloblastoma Glioblastoma Multiforme Anaplastic Astrocytoma High-grade Astrocytoma NOS Anaplastic Oligodendroglioma Anaplastic Ependymoma Ependymoma Diffuse Intrinsic Pontine Glioma

What is this study about?

This study is testing a new treatment called SurVaxM, which acts like a special vaccine for certain brain tumours in children and young adults. Normally, vaccines stop you from getting sick, but this one is designed to fight cancer. The idea is to teach your body's natural defence system, called the immune system, to find and destroy cancer cells. Many cancer cells, including those in the brain tumours being studied, have a protein called survivin on their surface, which healthy cells usually don’t have.

SurVaxM works by showing your immune system what this survivin protein looks like. Once your immune system knows to look for survivin, it can specifically target and get rid of cancer cells that have it. This could potentially help slow down tumour growth and stop the cancer from coming back. The vaccine is mixed with another ingredient, Montanide ISA 51, which helps make your immune response even stronger, so the vaccine can do its job better.

Researchers want to see if SurVaxM is safe and if it can help children and young adults with specific types of brain tumours, such as medulloblastoma, high-grade glioma, ependymoma, and newly found diffuse intrinsic pontine glioma (DIPG). This is a 'Phase 1' study, which means it’s one of the first times this treatment is being tested in children, and the main goal is to check its safety and find the best way to give it.

Key takeaways

It's a study testing a new cancer vaccine called SurVaxM.
The vaccine aims to teach your immune system to fight specific brain tumour cells.
It's for children and young adults (ages 1-21) with certain brain tumours.
You'll receive injections under the skin over a period of time.
The study checks for safety and how well the body reacts to the vaccine.
Follow-up will continue for up to three years after treatment ends.

Who may be eligible?

To join this study, the patient must be between 1 and 21 years old. They need to have certain types of brain tumours that have either grown or come back after previous treatment. These include medulloblastoma, glioblastoma multiforme, and various high-grade astrocytomas or ependymomas.

If a patient has a newly diagnosed diffuse intrinsic pontine glioma (DIPG) that affects a specific area of the brain, they might also be able to join without needing a previous biopsy. For all other tumour types, doctors will need to look at a small sample of the tumour to confirm the diagnosis.

An important requirement is that the patient's tumour must have a protein called survivin. This will be checked in a lab using a small piece of the tumour tissue. The patient and their family must also agree to take part and sign consent forms.

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.

Are you between 1 and 21 years old?
Do you have medulloblastoma, high-grade glioma, ependymoma, or newly diagnosed DIPG?
Has your tumour grown or come back, or is it newly diagnosed DIPG?
For most tumours, does a lab test show your tumour has the survivin protein?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the SurVaxM vaccine through injections under the skin. The study will have two main parts: a 'Priming Phase' and a 'Maintenance Phase'.

In the 'Priming Phase', you'll have four injections over the first six weeks. This means an injection at the very start, and then every two weeks. Along with the SurVaxM vaccine, you'll also receive another injection called sargramostim nearby, which helps boost your immune system's response to the vaccine. Each time you have these injections, you'll have appointments at the clinic.

If you complete the Priming Phase well and your condition stays stable or improves, you may then move to the 'Maintenance Phase'. In this phase, you'll receive the SurVaxM and sargramostim injections approximately every eight weeks, and this could continue for up to two years. After your treatment finishes, the study team will continue to follow your health and check for any side effects for up to three years, with clinic visits every three months.

Potential risks and benefits

Like all medical treatments, SurVaxM may have potential benefits, but also risks. Possible benefits could include helping your body's immune system fight the cancer more effectively and potentially slowing tumour growth or recurrence. However, as this is a Phase 1 study, the main goal is to understand its safety, and we don't know for sure if it will help everyone. There's a chance of side effects, which the study team will monitor closely. Any side effects experienced in a similar adult study were generally mild, like reactions at the injection site. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

Children's Hospital Los Angeles
Verified postcode
Los Angeles, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
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Palo Alto, United States
Children's Hospital Colorado
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Aurora, United States
Children's National
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Washington D.C., United States
University of Florida
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Gainesville, United States
Children's Healthcare of Atlanta
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Atlanta, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
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Chicago, United States
Roswell Park Comprehensive Cancer Center
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Buffalo, United States
Memorial Sloan Kettering
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New York, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, United States
Nationwide Children's Hospital
Verified postcode
Columbus, United States
UPMC Children's Hospital of Pittsburgh
Verified postcode
Pittsburgh, United States

Common questions

What is SurVaxM?

SurVaxM is a special vaccine designed to help your body's immune system fight certain types of cancer cells.

How is SurVaxM given?

It's given as an injection (a shot) just under the skin, similar to a regular vaccine.

What is survivin and why is it important?

Survivin is a protein often found on cancer cells but usually not on healthy cells. The vaccine teaches your immune system to look for and destroy cells with this protein.

How long does the study last?

The treatment phase could last for up to two years, with follow-up appointments continuing for up to three years after the last dose.

Will this vaccine cure my cancer?

This is a Phase 1 study, so the main purpose is to test the vaccine's safety and how well the body tolerates it. We cannot say if it will cure cancer at this stage.