Study on Metronomic Chemotherapy for Children and Teenagers with Relapsed or Refractory Wilms Tumor Using Vincristine, Irinotecan, Etoposide, Temozolomide, and Isotretinoin

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as Wilms tumor, which primarily affects children. The trial is investigating a treatment approach called metronomic chemotherapy, which involves using lower doses of chemotherapy drugs given more frequently. The medications being tested in this study include Vincristine, Irinotecan, Etoposide, Temozolomide, and Cis-Retinoic acid. These drugs are used to see if they can help control the disease in patients whose cancer has returned or has not responded to previous treatments.

The purpose of the study is to evaluate the safety and effectiveness of this treatment approach. Participants will receive the chemotherapy drugs over a period of approximately six months. The study will monitor how well the treatment controls the cancer and any side effects that may occur. The trial is divided into two stages: the first stage focuses on assessing the safety and feasibility of the treatment, while the second stage evaluates its effectiveness in controlling the disease.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI or CT-scan, to track the progress of the treatment. The study aims to determine if this combination of drugs can help manage the cancer more effectively and improve the quality of life for patients with relapsed or refractory Wilms tumor. The trial will also collect information on any adverse events or side effects experienced by participants during the treatment period.

1 joining the study

Upon joining the study, the patient will begin the first stage of the trial, which aims to evaluate the safety and feasibility of the chemotherapy regimen. This stage involves the administration of several medications.

2 medication administration

The patient will receive a combination of medications, including vincristine and irinotecan administered intravenously, and etoposide, temozolomide, and isotretinoin taken orally.

The specific dosage and frequency of these medications will be determined by the medical team based on the patient’s condition and response to treatment.

3 first cycle of treatment

The first cycle of treatment lasts approximately 12 weeks. During this period, the patient will be monitored for any dose-limiting toxicity, which refers to side effects that prevent an increase in dose or continuation of treatment.

4 evaluation of disease control

After completing two cycles of treatment, which is approximately 6 months, the patient’s response to the chemotherapy will be evaluated. This includes assessing whether the disease is controlled, meaning there is a complete response, partial response, or stable disease.

5 progression-free survival assessment

Progression-free survival will be measured from the start of the study to the date of disease progression or death from any cause. This assessment helps determine the effectiveness of the treatment.

6 overall survival assessment

Overall survival will be calculated from the start of the study to the date of death from any cause. This provides an overall measure of the treatment’s impact on the patient’s lifespan.

7 quality of life assessment

The patient’s quality of life will be evaluated using age-appropriate questionnaires at three time points: baseline, approximately at week 7, and week 13. This assessment aims to understand the impact of the treatment on the patient’s daily life and well-being.

8 tumor response evaluation

Tumor response will be assessed using imaging techniques such as CT scans or MRI. This evaluation will occur after each cycle of treatment, approximately every 3 months, to monitor changes in the tumor size or characteristics.

9 adverse events monitoring

Any adverse events, or side effects, occurring from the start of treatment until 30 days after the end of the study treatment will be reported and graded. This helps in understanding the safety profile of the treatment.

10 treatment feasibility assessment

The feasibility of the treatment will be assessed by examining the frequency of dose reductions or temporary stops of treatment. This includes summarizing the relative dose intensity for each drug and reasons for any permanent discontinuation.

Who Can Join the Study?

Patient must be at least 18 months old and younger than 18 years old.
If the patient is sexually active, they must agree to use proper birth control methods. This means using at least one very effective method or two different methods together, starting one month before treatment, during the study, and for six months after stopping the study drug. This applies to both females and males.
Written permission must be given by the patient’s parents or legal representative, and the patient must agree to participate if they are old enough to understand, following national guidelines.
Patient must be covered by the French “Social Security” system.
Patient must have a Wilms tumor that has come back or is not responding to treatment, confirmed by a tissue sample at diagnosis.
Patient must have already tried at least two different chemotherapy treatments, or one treatment if the tumor is high risk and no other cure is available. If only one treatment was tried, approval from study coordinators is needed.
The disease must be visible or measurable using imaging tests like MRI or CT scans.
Patient must have a performance status of at least 70% on the Karnofsky scale (for those older than 16) or the Lansky Play score (for those 16 or younger). These scales measure how well a patient can perform daily activities.
Patient must be able to take medicine by mouth, through a nasal gastric tube, or through a gastrostomy (a tube inserted into the stomach).
Patient must meet certain blood test criteria:
- Neutrophils (a type of white blood cell) must be greater than 1000 per cubic millimeter.
- Platelets (cells that help with blood clotting) must be greater than 75,000 per cubic millimeter.
- Transaminases (liver enzymes) must be no more than 3 times the normal limit, or 6 times if there are liver metastases (cancer spread to the liver).
- Total bilirubin (a substance made by the liver) must be no more than 2 times the normal limit, unless the patient has Gilbert’s disease (a mild liver disorder).
Creatinine (a waste product in the blood) must be no more than 1.5 times the normal limit, or the creatinine clearance (a test of kidney function) must be at least 60 milliliters per minute per 1.73 square meters of body surface area. If there is uncertainty, a test of cystatin (another kidney function marker) should confirm this.
Females who can have children must have a negative pregnancy test within 7 days before starting treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Wilms tumor cannot participate. Wilms tumor is a type of kidney cancer that mostly affects children.
Patients who are not children or teenagers are excluded. The study is specifically for young individuals.
Patients who are not experiencing a relapsed or refractory Wilms tumor cannot join. Relapsed means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who cannot safely receive the specific chemotherapy drugs used in the study are excluded. These drugs include Vincristine, Irinotecan, Etoposide, Temozolomide, and Cis-Retinoic acid.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible.
Patients who are pregnant or breastfeeding cannot participate, as the study drugs may affect the baby.
Patients with other serious health conditions that could interfere with the study treatment are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Institut Gustave Roussy	Villejuif	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Regional Universitaire De Nancy	Nancy	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Institut Des Neurosciences De La Timone	Marseille	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Ccmofh Litw Bzwckm	Lyon	France
Cbmuwv Oflom Lrhyyzx	Lille	France
Hwzvnseg Uupjbkbmmhidvy Slcifgcmlw &ovtkko Hwuqpyw df Hxnkwoxjjzi	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Vincristine is a chemotherapy medication used to treat various types of cancer. In this trial, it is part of a combination therapy aimed at treating relapsed or refractory Wilms tumor in children and teenagers. Vincristine works by stopping the growth of cancer cells.

Irinotecan is another chemotherapy drug included in the trial. It is used to treat cancers by interfering with the DNA of cancer cells, preventing them from multiplying. In this study, it is combined with other medications to enhance its effectiveness against Wilms tumor.

Etoposide is a chemotherapy medication that helps to slow or stop the growth of cancer cells. It is part of the metronomic chemotherapy regimen being tested in the trial for its potential to control the disease in patients with Wilms tumor.

Temozolomide is a chemotherapy drug that works by damaging the DNA of cancer cells, which can lead to their death. It is included in the trial to assess its role in the combination therapy for treating Wilms tumor.

Cis-Retinoic Acid is a form of vitamin A used in cancer treatment. It helps to control the growth and spread of cancer cells. In this trial, it is part of the metronomic chemotherapy regimen being evaluated for its safety and effectiveness in treating Wilms tumor.

Wilms Tumor – Wilms tumor is a rare type of kidney cancer that primarily affects children. It typically presents as a painless abdominal mass, which may be accompanied by symptoms such as fever, blood in the urine, or high blood pressure. The disease originates from immature kidney cells and can vary in its rate of growth and spread. In some cases, it may remain localized to the kidney, while in others, it can spread to nearby tissues or distant organs. The progression of Wilms tumor can be influenced by factors such as the tumor’s size, stage, and histological characteristics. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2022-502687-20-00

Protocol code:

MetroWilms-1906

NCT ID:

NCT05384821

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Metronomic Chemotherapy for Children and Teenagers with Relapsed or Refractory Wilms Tumor Using Vincristine, Irinotecan, Etoposide, Temozolomide, and Isotretinoin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?