Study of Propranolol and Vinorelbine for Children and Teenagers with Refractory or Relapsing Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for children and teenagers with refractory or relapsing solid tumors. These are types of cancer that have not responded to previous treatments or have returned after treatment. The study will use a combination of two medications: Propranolol and Vinorelbine. Propranolol is commonly used to treat heart conditions, while Vinorelbine is a chemotherapy drug used to treat cancer. The purpose of the study is to determine the highest dose of Vinorelbine that can be given safely when combined with Propranolol.

Participants in the study will take Vinorelbine three times a week and Propranolol daily. The study will monitor how well participants tolerate the treatment and will assess any side effects. The trial will also evaluate how effective the treatment is in controlling the cancer over a period of six months. The study aims to find the best dose that balances effectiveness with minimal side effects.

This trial is important for finding new ways to treat children and teenagers with difficult-to-treat cancers. By combining these two medications, researchers hope to improve outcomes for patients who have limited treatment options. The study will provide valuable information on the safety and potential benefits of this treatment combination.

1 initial treatment phase

The treatment involves the use of two medications: propranolol and vinorelbine. Propranolol is administered daily in the form of an oral solution called HEMANGIOL, with a concentration of 3.75 mg/mL.

Vinorelbine is given in the form of soft capsules, known as NAVELBINE, with dosages of 20 mg and 30 mg. It is taken orally three times a week.

The main goal during this phase is to determine the maximum dose of vinorelbine that can be tolerated when combined with daily propranolol.

2 monitoring and assessment

Throughout the treatment, regular monitoring is conducted to assess the body’s response to the medications. This includes checking for any side effects or toxicities.

The primary focus is on identifying any severe side effects, such as significant drops in blood cell counts or other serious reactions, which may require adjustments to the treatment plan.

3 evaluation of treatment effectiveness

The effectiveness of the treatment is evaluated by measuring progression-free survival and overall survival rates after six months of treatment.

Progression-free survival refers to the length of time during and after the treatment that the patient lives without the disease getting worse.

Overall survival is the duration from the start of the study until death from any cause.

4 completion of treatment cycle

The initial treatment cycle lasts for 56 days, during which the maximum tolerated dose is assessed.

After completing the cycle, further treatment decisions are made based on the patient’s response and tolerance to the medications.

Who Can Join the Study?

Must have a confirmed diagnosis of cancer or a specific type of tumor that doesn’t need a biopsy or surgery.
No known allergies to the treatment being tested.
Must be able to swallow softgel capsules, liquid medicine, or tablets.
Expected to live for more than 3 months.
Must be part of a social security program.
If applicable, must use effective birth control during the treatment.
Must have signed a consent form. For minors, parents or guardians must give permission, and minors will receive information they can understand.
Must have a disease that has returned or not responded to standard treatments, or for which no effective standard treatment exists.
Must have measurable tumors according to specific medical criteria.
Must be between 4 and 24 years old.
Must have a performance score greater than 50, which measures the ability to perform daily activities.
Blood conditions: Must have a certain level of white blood cells and platelets.
Kidney function: Must have creatinine levels within a specific range or a certain level of kidney clearance.
Liver function: Must have specific levels of bilirubin and liver enzymes, with different criteria if there are liver metastases.
No other organ damage above a certain level according to medical guidelines.

Who Cannot Join the Study?

Patients who are not children or teenagers.
Patients who do not have a refractory or relapsing solid tumor. Refractory means the tumor does not respond to treatment, and relapsing means the tumor has returned after treatment.
Patients who cannot take oral medications. Oral means the medication is taken by mouth.
Patients who are not able to take navelbine or propranolol. Navelbine is a type of cancer medication, and propranolol is a medication often used to treat heart conditions.
Patients who are not available to take medication three times a week.
Patients who are not available to take medication daily.
Patients who are not willing to follow the study procedures.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cgzsen Lgzt Btsyhd	Lyon	France
Ailglnutse Pnlduwmi Heuwrfkc Dc Mvjylwmiz	Marseille	France
Ccey Dz Nzgda	Vandoeuvre Les Nancy	France
Hxnuxsuz Uukaybfuoeksww Srbfxfkwgw &hdcdna Hhfgusa dq Hhilrttkxxh	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	03.08.2020

Trial locations

Investigated drugs:

Propranolol (HEMANGIOL®) is a medication commonly used to treat high blood pressure, certain types of irregular heartbeats, and other heart-related conditions. In this clinical trial, it is being used to explore its potential benefits in treating children and teenagers with solid tumors that have not responded to other treatments or have returned after treatment. The role of propranolol in this study is to work in combination with another medication to see if it can help improve treatment outcomes for these patients.

Vinorelbine (NAVELBINE®) is a chemotherapy drug that is used to treat various types of cancer by slowing or stopping the growth of cancer cells. In this trial, vinorelbine is given in an oral form and is administered three times a week. The study aims to find the highest dose of vinorelbine that can be tolerated when used together with propranolol. The goal is to determine if this combination can be effective in treating children and teenagers with solid tumors that are difficult to treat.

Investigated diseases:

Refractory/Relapsing Solid Tumor in Children and Teenagers – This condition involves solid tumors that do not respond to standard treatments or return after initial treatment in children and teenagers. Solid tumors are abnormal masses of tissue that can occur in various parts of the body, excluding blood-related cancers. These tumors can grow and spread to other parts of the body, making them challenging to treat. The progression of the disease can vary depending on the type and location of the tumor. In some cases, the tumor may remain localized, while in others, it may metastasize to distant organs. The condition requires ongoing monitoring to assess changes in tumor size and spread.

Trial ID:

2024-517185-42-00

Protocol code:

PROVIN

NCT ID:

NCT02897986

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Propranolol and Vinorelbine for Children and Teenagers with Refractory or Relapsing Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?