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

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

2 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Lenvatinib – Lenvatinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating various types of relapsed or refractory solid tumors in children, adolescents, and young adults, including High Grade Glioma, Rhabdomyosarcoma, and Ewing Sarcoma. The medication works by inhibiting certain proteins involved in tumor growth and blood vessel formation, thereby slowing down or stopping the progression of cancer. Lenvatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512135-80-00Protocol codeMK-7902-013Estimated enrolment111 patientsSponsorMerck Sharp & Dohme LLC

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