Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

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What is this study about?

This clinical trial is focused on studying treatments for pediatric cancer, which refers to various types of cancer that occur in children. The study involves several medications, including Votubia (active ingredient: everolimus), Lynparza (active ingredient: olaparib), INC280 (active ingredient: capmatinib), AZD6738 (active ingredient: ceralasertib), Bavencio (active ingredient: avelumab), Peposertib (active ingredient: peposertib), Enasidenib Mesilate, and Futibatinib. The purpose of the study is to determine if the doses of these drugs, which are safe and effective in adults, are also safe and effective in children and adolescents with cancer that has returned or is not responding to standard treatments.

Participants in the study will receive one or more of these medications, which are administered orally or through intravenous infusion, depending on the drug. The study will monitor the safety of these medications in children and adolescents and assess their effectiveness in treating specific types of cancer. The trial will also explore how these drugs work in patients with certain genetic changes in their tumors, which may affect how well the treatment works.

The study will take place over several years, with participants being closely monitored for any side effects and the response of their cancer to the treatment. The goal is to find the best dose that balances safety and effectiveness for young patients. This research could lead to new treatment options for children and adolescents with cancer that is difficult to treat with existing therapies.

1 joining the trial

Upon joining the trial, the patient will receive detailed information about the study, including its purpose and the treatments involved. Written informed consent from the patient or their legal representative is required before any trial-specific procedures begin.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments. The patient must have a type of cancer that has not responded to standard treatments.

3 treatment phase I

The patient will begin the first phase of treatment. This phase aims to determine the safe dosage of the medication. The patient will receive one or more of the following medications: Votubia, Lynparza, INC280, AZD6738, LEE011, Bavencio, Peposertib, Enasidenib Mesilate, Futibatinib. The medications are administered orally or intravenously, depending on the specific drug.

4 monitoring and adjustments

Throughout the treatment, the patient will be closely monitored for any side effects or adverse reactions. Adjustments to the dosage may be made based on the patient’s response to the treatment.

5 treatment phase II

In the second phase, the focus is on evaluating the effectiveness of the treatment. The patient will continue to receive the medication at the determined safe dosage. The response to the treatment will be assessed through regular medical evaluations and imaging tests.

6 follow-up

After completing the treatment phases, the patient will have follow-up appointments to monitor their health and any long-term effects of the treatment. These appointments will help determine the overall success of the treatment and its impact on the patient’s condition.

Who Can Join the Study?

Patients must have a type of cancer that has come back or gotten worse after standard treatment, or for which no effective standard treatment exists.
Patients must be able to comfortably swallow whole capsules or tablets for all oral medications, unless an oral solution is available. If needed, taking medicine through a feeding tube is allowed.
Written informed consent must be given by the parents or legal representative, the patient, and the patient must agree if they are old enough to understand, before any study-specific procedures are done.
Patients must be part of a social security system or have similar benefits according to local rules.
Patients must be younger than 18 years old at the time of joining the study.
Patients must have had advanced testing of their tumor to understand its genetic makeup, especially if the cancer has come back or gotten worse. In some cases, testing done at the time of diagnosis may be accepted.
Patients must have a disease that can be measured or evaluated using standard imaging techniques for their type of tumor.
Patients must have a performance status score of at least 70% on the Karnofsky scale (for those older than 12 years) or the Lansky Play score (for those 12 years or younger). This score measures the patient’s ability to perform daily activities.
Patients must have a life expectancy of at least 3 months.
Patients must have adequate organ function as defined in the study protocol.
Patients must be able to follow the study schedule and manage any side effects.
Females who can have children must have a negative pregnancy test within 72 hours before starting treatment. Sexually active patients must agree to use a highly effective method of birth control.

Who Cannot Join the Study?

Patients who do not have pediatric cancer cannot participate.
Patients who are not within the age range specified for the study cannot participate.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are taking other medications that might interfere with the study cannot participate.
Patients who have had a recent surgery or medical procedure that might interfere with the study cannot participate.
Patients who have a history of allergic reactions to the study drugs cannot participate.
Patients who are part of another clinical trial cannot participate.

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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Infantil Universitario Nino Jesus	Madrid	Spain
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Pellegrin Hospital	Bordeaux	France
Institut Des Neurosciences De La Timone	Marseille	France
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Rigshospitalet	Copenhagen	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Caiinf Lhni Bvluhp	Lyon	France
Ajmnocd Oecagskttfw Uyghjsmhisyea Ctybgzzxiznv Dhdvx Sxlnpe E Dbict Sropriw Du Toolap	Turin	Italy
Cnunzj Hkgrxvwqkid Rkeaipnm Dvyriwedsgpltb	Angers	France
Hykeljwg Vwoe dlwcnjpg	Barcelona	Spain
Cpkkwl Oshbd Lnpmmem	Lille	France
Hdaamwna Uoexhmotswneod Szntnpvgne &mgnrpu Huhchyj dy Hzdtqihirhh	STRASBOURG, Alsace	France
Ikdkhmvl Clero	Paris	France

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	03.08.2016
France	Recruiting	03.08.2016
Italy	Recruiting	03.08.2016
Spain	Recruiting	03.08.2016
The Netherlands	Recruiting	03.08.2016

Trial locations

Investigated drugs:

AcSé-ESMART is a clinical trial that investigates different medications for treating tumors that have come back or do not respond to standard treatments. The trial aims to find out if the medications used in adults are safe and effective for children and adolescents with these types of tumors. The study looks at how these medications work in patients with specific genetic changes in their tumors, as well as in patients without these changes.

Investigated diseases:

Neoplasm

Pediatric Cancer – Pediatric cancer refers to a group of cancers that occur in children and adolescents. These cancers can originate in various parts of the body, including the blood, brain, bones, and organs. The progression of pediatric cancer varies depending on the type and location of the cancer. Some cancers may grow rapidly, while others develop more slowly. As the cancer progresses, it can spread to other parts of the body, a process known as metastasis. The symptoms and impact on the child’s health can differ significantly based on the specific type of cancer and its stage.

Trial ID:

2024-514791-40-00

Protocol code:

2016/2369

NCT ID:

NCT02813135

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?