Study of Abemaciclib with Irinotecan and Temozolomide for Children and Young Adults with Relapsed or Refractory Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for relapsed/refractory solid tumors in children and young adults. These are types of cancer that have returned or are not responding to standard treatments. The study involves the use of several medications, including Abemaciclib, which is also known by its code name LY2835219. This medication is being tested in combination with other drugs such as Irinotecan and Temozolomide. In one part of the study, Abemaciclib is combined with Irinotecan and Temozolomide, while in another part, it is combined with Temozolomide alone. Additionally, for patients with a specific type of cancer called neuroblastoma, Abemaciclib is combined with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide.

The purpose of this study is to find the best dose of Abemaciclib when used with these other medications. The study is divided into different parts, each testing a different combination of drugs. Participants will receive the study medications either by mouth or through an infusion, which is a way of delivering medicine directly into the bloodstream. The study will monitor how the body responds to these treatments and will look for any side effects that might occur.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information that could help improve treatment options for young patients with these challenging types of cancer. The trial is expected to continue until 2025, allowing researchers to gather comprehensive data on the safety and effectiveness of these drug combinations.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Participants must have a measurable or evaluable disease and meet specific health criteria, such as adequate organ function and a life expectancy of at least 8 weeks.

2 treatment phase – part a

In Part A, participants receive a combination of abemaciclib, irinotecan, and temozolomide.

Irinotecan is administered through infusion, while abemaciclib and temozolomide are taken orally as tablets.

The dosage and frequency are determined based on individual tolerance and response to the treatment.

3 treatment phase – part b

In Part B, participants receive a combination of abemaciclib and temozolomide.

Both medications are taken orally in tablet form.

The treatment continues with regular monitoring to assess effectiveness and any side effects.

4 treatment phase – part c

In Part C, participants with neuroblastoma receive a combination of abemaciclib, dinutuximab, GM-CSF, irinotecan, and temozolomide.

This phase involves a combination of oral and infusion medications, with specific dosages tailored to the participant’s needs.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track the participant’s response to the treatment and any side effects.

Blood tests and other assessments are performed to ensure safety and adjust treatment as necessary.

6 end of trial

The trial is expected to conclude by March 2025.

Participants will undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

Participants must be 18 years old or younger for Parts A and B, and younger than 21 years for Part C.
Participants must weigh at least 10 kilograms and have a body surface area (BSA) of at least 0.5 for Parts A and B, and at least 0.2 for Part C. BSA is a way to measure the surface area of the body.
Participants must have a type of cancer called a relapsed/refractory solid tumor, which means the cancer has returned or is not responding to treatment. This includes tumors in the brain or spinal cord but does not include lymphoma.
For Parts B and C, participants with a specific type of cancer called neuroblastoma may be excluded from Part B unless approved.
Participants must have a disease that can be measured or evaluated using specific guidelines called RECIST v1.1 or RANO.
Participants younger than 16 years must have a Lansky score of at least 50, and those 16 years or older must have a Karnofsky score of at least 50. These scores measure the ability to perform daily activities.
Participants must have stopped all previous cancer treatments and recovered from any immediate side effects to a mild level before joining the study.
Participants must be able to swallow or have a tube for feeding.
Participants must have good blood and organ function at least 2 weeks before starting the study drug.
Females who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during the trial.
Participants must have a life expectancy of at least 8 weeks and be able to complete at least one cycle of treatment.
Participants and their caregivers must be willing to be available for the entire duration of the trial.

Who Cannot Join the Study?

Patients who have not recovered from previous treatments or surgeries.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently.
Patients with allergies to the study medications.
Patients with certain types of infections that are not well controlled.
Patients with a history of certain heart problems.
Patients with a history of certain liver or kidney problems.
Patients who are taking medications that could interfere with the study drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country	Status
Hqhzargu Vwrx dsizqkxn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	11.11.2020

Trial locations

Investigated drugs:

Abemaciclib is a medication used in this trial to treat pediatric and young adult patients with relapsed or refractory solid tumors. It is being tested in combination with other drugs to determine the best dose for treatment. Abemaciclib works by inhibiting certain proteins that are involved in the growth and division of cancer cells, potentially slowing down or stopping the progression of the disease.

Irinotecan is a chemotherapy drug used in this trial in combination with abemaciclib and temozolomide. It works by interfering with the DNA of cancer cells, preventing them from multiplying and causing them to die. This medication is used to treat various types of cancer, including those that have returned or are resistant to other treatments.

Temozolomide is another chemotherapy drug included in this trial. It is used alongside abemaciclib and, in some parts of the study, with irinotecan. Temozolomide works by damaging the DNA of cancer cells, which can lead to their death. It is often used to treat brain tumors and other solid tumors.

Dinutuximab is a type of immunotherapy used in this trial for patients with relapsed or refractory neuroblastoma. It is a monoclonal antibody that targets specific proteins on the surface of cancer cells, helping the immune system recognize and destroy these cells.

GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) is a therapy used in this trial to boost the immune system. It helps increase the production of white blood cells, which can enhance the body’s ability to fight cancer. In this study, it is used in combination with dinutuximab, irinotecan, and temozolomide for treating neuroblastoma.

Investigated diseases:

Neoplasm

Relapsed/Refractory Solid Tumors – These are types of cancerous growths that have returned after treatment or have not responded to standard therapies. Solid tumors can occur in various organs and tissues, forming a mass of abnormal cells. When these tumors relapse, it means they have come back after a period of improvement. Refractory tumors are those that do not respond to treatment from the beginning. The progression of these tumors can vary widely depending on the type and location of the tumor. They may grow slowly or rapidly, potentially affecting nearby tissues and organs.

Trial ID:

2023-506778-11-00

Protocol code:

I3Y-MC-JPCS

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Abemaciclib with Irinotecan and Temozolomide for Children and Young Adults with Relapsed or Refractory Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?