Desmoid tumour Trials in Disease

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

This clinical trial is investigating a treatment combination for children and teenagers with solid tumours that have either not responded to previous treatments or have returned after treatment. The study uses two medications together: propranolol and vinorelbine.

Main inclusion criteria:

• Participants must be between 4 and 24 years old
• Must have a confirmed diagnosis of cancer or a specific type of tumour
• Must have a disease that has returned or not responded to standard treatments, or for which no effective standard treatment exists
• Must have measurable tumours according to specific medical criteria
• Must be able to swallow softgel capsules, liquid medicine, or tablets
• Expected to live for more than 3 months
• Must have adequate blood cell counts, kidney function, and liver function
• Must have a performance score greater than 50, which measures the ability to perform daily activities
• For minors, parents or guardians must give permission

Main exclusion criteria:

• Patients who cannot take oral medications
• Patients who are unable to take navelbine or propranolol
• Patients who are not available to take medication three times a week and daily
• Patients who are pregnant or breastfeeding
• Patients who are participating in another clinical trial
• Patients who have other medical conditions that might interfere with the study

Focus and goal of the trial:

The main purpose of this study is to determine the highest dose of vinorelbine that can be given safely when combined with propranolol. The trial follows a structured approach with several phases. In the initial treatment phase, participants take propranolol daily as an oral solution and vinorelbine in capsule form three times a week. Throughout the treatment, regular monitoring is conducted to assess the body's response and check for any side effects, particularly serious reactions such as significant drops in blood cell counts.

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 treatment that the patient lives without the disease getting worse. 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.

Investigational drugs:

The trial uses two medications in combination. Propranolol, marketed as HEMANGIOL, is a medication commonly used to treat high blood pressure, certain types of irregular heartbeats, and other heart-related conditions. It works by blocking beta-adrenergic receptors, which reduces heart rate and blood pressure. In this study, it is being explored for its potential to enhance the effects of cancer treatment when used alongside chemotherapy.

Vinorelbine, marketed as NAVELBINE, 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. 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, with the goal of determining if this combination can be effective in treating children and teenagers with solid tumours that are difficult to treat.