Study on the Effectiveness of Bevacizumab and Drug Combination for Children with Recurrent or Progressive Medulloblastoma, Ependymoma, and ATRT

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What is this study about?

This clinical trial is focused on studying treatments for children with certain types of brain tumors, specifically medulloblastoma, ependymoma, and atypical teratoid rhabdoid tumor (ATRT). These are serious conditions where abnormal cells form in the tissues of the brain. The study aims to explore the effectiveness of a combination of medications that target the blood vessels that supply the tumor, a process known as anti-angiogenesis therapy. The medications being tested include Cytarabine, Celecoxib, Cyclophosphamide, Etoposide, Bevacizumab, Fenofibrate, and Thalidomide. Some of these medications are given as injections, while others are taken orally as capsules.

The purpose of the study is to determine how well these treatments work in stopping the growth of these tumors. Participants in the study will receive these medications over a period of time, and their health will be monitored closely by the research team. The study will look at how the tumors respond to the treatment, whether they shrink, stay the same, or grow, and how long the patients remain free of tumor growth. The study will also monitor the overall health and quality of life of the participants during and after the treatment.

Throughout the study, participants will receive regular check-ups and tests to track their progress. The research team will evaluate the safety and side effects of the treatments, ensuring that any adverse effects are managed promptly. The study is designed to gather important information that could lead to better treatment options for children with these challenging brain tumors in the future.

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.

Blood tests and imaging studies may be performed to ensure normal organ and bone marrow function.

2 treatment initiation

The treatment begins with the administration of medications designed to target the specific condition.

Medications include cytarabine, celecoxib, cyclophosphamide, etoposide, bevacizumab, fenofibrate, and thalidomide.

3 medication schedule

Cytarabine is administered as a solution for injection into the intrathecal space.

Celecoxib is taken orally in capsule form.

Cyclophosphamide is administered as an oral solution.

Etoposide is given as an intravenous infusion.

Bevacizumab is administered as an intravenous infusion.

Fenofibrate is taken orally in capsule form.

Thalidomide is taken orally in capsule form.

4 ongoing monitoring

Regular monitoring is conducted to assess the response to treatment and any side effects.

Blood tests and imaging studies are repeated at specified intervals to track progress.

5 evaluation of response

The response to treatment is evaluated at 6 months to determine effectiveness.

The evaluation includes checking for complete response, partial response, stable disease, or lack of recurrence.

6 follow-up assessments

Follow-up assessments are conducted at 6, 12, 24, and 36 months to evaluate overall survival and progression-free survival.

Quality of life and performance status are also assessed during these follow-ups.

Who Can Join the Study?

  • Patients must have recurrent or progressive medulloblastoma, ependymoma, or atypical teratoid rhabdoid tumor (ATRT). This means the disease has returned or is getting worse.
  • For medulloblastoma, ependymoma, or ATRT, there must be at least one site of the disease that has not been treated again.
  • The original diagnosis or relapse must be confirmed through a test called a histological confirmation, which examines tissue under a microscope.
  • Participants can be either female or male and must be aged from 0 to less than 20 years at the time of the original diagnosis.
  • Participants must have normal organ and bone marrow function. This includes:
    • ALT (a liver enzyme) less than 5 times the normal limit.
    • Creatinine (a kidney function marker) less than 1.5 times the normal limit for their age.
    • White blood cells (WBC) greater than 1000 per mm3.
    • Platelets greater than 20,000 per mm3.

    If WBC is less than 2000 per mm3 or platelets are less than 50,000 per mm3, treatment will start at a lower dose.

  • Participants must have a performance status score of at least 50. This is a measure of their ability to perform daily activities. For children under 12, a similar scale called the Lansky play scale is used.
  • Written informed consent must be provided by the patients and/or their parents. This means they agree to participate after understanding the study details.

Who Cannot Join the Study?

  • Patients with recurrent or progressive medulloblastoma, ependymoma, or atypical teratoid rhabdoid tumor (ATRT) cannot participate. These are specific types of brain tumors.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not male or female cannot participate, as the study is open to both genders.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Oslo Universitetssykehus HF Oslo Norway
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Vaesterbotten Umea Sweden
St. Olavs Hospital HF Trondheim Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Odense University Hospital Odense Denmark
Region Skane Skanes Universitetssjukhus Lund Sweden
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Aalborg University Hospital Aalborg Denmark
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Uniklinikum Salzburg Salzburg Austria
Cretcg Lqky Bzcmjr Lyon France
Ayizipjqgf Pojhubwz Hylyqjjp Dg Mqxkciddq Marseille France
Uwpnooz Uldyimyjfe Hfqxsehr Uppsala Sweden
Hwweg Bxaxji Ho Bergen Norway
Jevniquo Ktylot Uwjpbtuirl Linz Austria
Cbijaw Oatfs Lhweuyv Lille France
Hfjygvrw Ulflxlhwwytwfs Sifzzbqmwr &ymuocf Hgpxozq dq Hcbjaxywuty STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
09.04.2014
Czechia Czechia
Recruiting
09.04.2014
Denmark Denmark
Recruiting
09.04.2014
France France
Recruiting
09.04.2014
Norway Norway
Recruiting
09.04.2014
Spain Spain
Recruiting
09.04.2014
Sweden Sweden
Recruiting
09.04.2014

Trial locations

Metronomic Therapy is a treatment approach that involves giving patients lower doses of chemotherapy drugs more frequently. This method aims to minimize side effects while still effectively targeting cancer cells. In this trial, metronomic therapy is used to help control the growth of tumors by continuously attacking the cancer cells over time.

Anti-Angiogenic Therapy is a type of treatment that focuses on stopping the formation of new blood vessels that tumors need to grow. By cutting off the blood supply, this therapy aims to starve the tumor, preventing it from getting the nutrients it needs to expand. This approach is particularly useful in treating cancers that are known to rely heavily on blood vessel growth.

Investigated diseases:

Medulloblastoma – Medulloblastoma is a type of brain tumor that originates in the cerebellum, the part of the brain that controls balance and coordination. It is most commonly found in children and can spread to other parts of the brain and spinal cord. The disease progresses as the tumor grows, potentially causing symptoms such as headaches, nausea, and balance problems. As it advances, it may lead to increased intracranial pressure and neurological deficits. The tumor can also metastasize through the cerebrospinal fluid, affecting other areas of the central nervous system.

Ependymoma – Ependymoma is a tumor that arises from ependymal cells lining the ventricles of the brain and the central canal of the spinal cord. It can occur at any age but is more common in children. The disease progresses as the tumor enlarges, potentially causing symptoms like headaches, nausea, and vision problems due to increased intracranial pressure. In the spinal cord, it may lead to back pain and neurological deficits. Ependymomas can spread within the central nervous system but rarely metastasize outside it.

Atypical Teratoid Rhabdoid Tumor (ATRT) – Atypical Teratoid Rhabdoid Tumor (ATRT) is a rare and aggressive tumor that typically occurs in the central nervous system, often in the brain. It primarily affects young children and is characterized by rapid growth. As the disease progresses, it can cause symptoms such as headaches, vomiting, and changes in behavior or motor skills due to increased pressure on the brain. ATRT can spread to other parts of the brain and spinal cord. The tumor’s aggressive nature often leads to significant neurological impairment as it advances.

Trial ID:
2024-515626-92-00
NCT ID:
NCT01356290
Trial Phase:
Therapeutic exploratory (Phase II)

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