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

Verified siteRegistered drugNo 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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Propranolol

    This medication is administered orally and is currently being studied in combination with another drug for its potential use in treating children and teenagers with refractory or relapsing solid tumors. Propranolol is a well-known beta-blocker primarily used to manage heart conditions and anxiety. It works by blocking beta-adrenergic receptors, which reduces heart rate and blood pressure. In this trial, its role is being explored for its potential to enhance the effects of cancer treatment.

  • Vinorelbine

    This medication is also administered orally and is being tested in combination with propranolol for its effectiveness in treating children and teenagers with refractory or relapsing solid tumors. Vinorelbine is a chemotherapy drug that belongs to the class of vinca alkaloids. It works by disrupting the formation of microtubules, which are essential for cell division, thereby inhibiting cancer cell growth. The trial aims to determine the maximum tolerated dose when given three times a week alongside daily propranolol.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517185-42-00Protocol codePROVINEstimated enrolment58 patientsSponsorCentre Hospitalier Regional De Marseille

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