Study of Lenvatinib for Children and Young Adults with Relapsed or Refractory Solid Tumors, Including High Grade Glioma and Rhabdomyosarcoma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called lenvatinib in young patients who have certain types of cancer that have returned or are not responding to treatment. The cancers being studied include High Grade Glioma, Rhabdomyosarcoma, Ewing Sarcoma, and other solid tumors, except for osteosarcoma. The purpose of the study is to evaluate how well lenvatinib works in treating these cancers and to assess its safety in children, adolescents, and young adults.

Participants in the study will take lenvatinib in the form of a capsule, which is taken by mouth. The study will monitor the response of the tumors to the treatment over a period of time, specifically looking at the changes in the size of the tumors and any side effects experienced by the participants. The study aims to determine the effectiveness of lenvatinib in shrinking the tumors and improving the condition of the patients.

The study will last for several weeks, during which participants will receive regular check-ups and assessments to track their progress. The researchers will use specific criteria to evaluate the response of the tumors to the treatment, ensuring that the results are accurate and reliable. This study is an important step in finding better treatment options for young patients with these challenging types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as age and type of tumor. The study is for individuals between ages 2 and 21 with certain types of solid tumors, excluding osteosarcoma.

Participants must have a documented relapsed or refractory solid tumor and meet other health criteria, including adequate organ function and blood pressure control.

2 treatment initiation

The treatment involves taking lenvatinib, which is administered orally in the form of capsules.

The dosage and frequency of lenvatinib are determined by the study team based on individual health assessments.

3 treatment duration

The treatment continues for a specified period, with regular monitoring to assess the response to the medication.

The primary goal is to evaluate the Objective Response Rate (ORR) at Week 16, which measures how the tumor responds to the treatment.

4 monitoring and assessments

Throughout the study, regular assessments are conducted to monitor health and response to the treatment. This includes measuring tumor size and checking for any side effects.

The study uses specific criteria, such as RECIST 1.1 or RANO, to evaluate the tumor’s response.

5 completion of study

The study is estimated to end by February 19, 2025. Participants will have a final assessment to determine the overall response to the treatment.

The study aims to gather data on the effectiveness and safety of lenvatinib in treating relapsed or refractory solid tumors in young patients.

Who Can Join the Study?

Participants must be between the ages of 2 and 21.
Must have a type of cancer called High Grade Glioma (HGG), Rhabdomyosarcoma (RMS), Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (pPNET), or other solid tumors, but not osteosarcoma.
The cancer must have come back or not responded to treatment, and this must be confirmed by examining tissue or cells under a microscope.
The cancer must be measurable, meaning it can be seen and measured using specific medical criteria.
Participants must have a certain level of daily activity and ability to care for themselves, measured by a score system: Lansky Play Score for those 16 and under, and Karnofsky Performance Status (KPS) for those over 16.
Any brain-related symptoms must have been stable for at least 7 days before joining the study.
Participants must have organs that are working well enough.
There should be no signs of a kidney problem called nephrotic syndrome.
Blood pressure must be under control, with or without medication.
The heart must be functioning well enough.
The nervous system must be functioning well enough.
Participants must have recovered from any side effects of previous cancer treatments to a certain level, except for hair loss, hearing problems, and some nerve issues.
Male participants must agree to use approved birth control during the study and for at least 7 days after the last dose, and they must not donate sperm during this time.

Who Cannot Join the Study?

Patients who are not between the ages of 2 and 21.
Patients who do not have one of the following conditions: High Grade Glioma (HGG), Rhabdomyosarcoma (RMS), Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor (pPNET), or other solid tumor types, except for osteosarcoma.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Femjlgdx nrrbfhhcw Mlfkf a Hxhfjjb	Prague	Czechia
Azdawcgaat Ptmynsrx Heelzddy Dz Mihegmelf	Marseille	France
Avsoauw Ojrispwlwyt Uwvqesgyjbgkr Cnmyguofxgrs Dwrrg Srnxff E Ddzym Sizdlnu Dl Trhjec	Turin	Italy
Ijkglups Chwuw	Paris	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	25.05.2021
France	Not recruiting	25.05.2021
Italy	Not recruiting	25.05.2021
Spain	Not recruiting	25.05.2021

Trial locations

Investigated drugs:

Lenvatinib

Lenvatinib is a medication used in this clinical trial to evaluate its effectiveness and safety in treating children, adolescents, and young adults with solid tumors that have returned or are resistant to treatment. It works by blocking certain proteins that help cancer cells grow and spread, aiming to reduce the size of the tumors and slow down their progression.

Investigated diseases:

Glioma

High Grade Glioma – This is a type of brain tumor that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and aggressive behavior, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor’s location but may include headaches, seizures, and neurological deficits. The disease tends to progress quickly, leading to increased symptoms over time.

Rhabdomyosarcoma – This is a cancerous tumor that arises from skeletal muscle tissue, most commonly affecting children. It can occur in various parts of the body, including the head, neck, and limbs. The tumor is known for its rapid growth and potential to spread to other areas. Symptoms depend on the tumor’s location and may include a noticeable lump, pain, or functional impairment in the affected area.

Ewing Sarcoma – This is a rare type of cancer that typically forms in bones or the soft tissue around bones, often affecting children and young adults. It is characterized by a small, round, blue cell tumor that can grow quickly and spread to other parts of the body. Common symptoms include pain and swelling at the tumor site, fever, and fatigue. The disease can progress rapidly, leading to increased discomfort and potential complications.

Peripheral Primitive Neuroectodermal Tumor (pPNET) – This is a rare, aggressive cancer that originates from primitive nerve cells outside the central nervous system. It is closely related to Ewing Sarcoma and often affects children and young adults. The tumor can develop in various parts of the body, including the chest, pelvis, and limbs. Symptoms may include pain, swelling, and neurological issues, depending on the tumor’s location and size.

Trial ID:

2024-512135-80-00

Protocol code:

MK-7902-013

NCT ID:

NCT04447755

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Lenvatinib for Children and Young Adults with Relapsed or Refractory Solid Tumors, Including High Grade Glioma and Rhabdomyosarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?