RecruitingPhase 1Phase 2NCT05384821

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor


Sponsor

Centre Oscar Lambret

Enrollment

28 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.


Eligibility

Min Age: 18 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing metronomic chemotherapy — a strategy of giving lower doses of chemotherapy continuously rather than in large, spaced-out cycles — in children with Wilms tumor (a kidney cancer most common in children) whose cancer has returned or stopped responding to standard treatment. **You may be eligible if...** - You are between 18 months and 17 years old - You have been diagnosed with Wilms tumor that has relapsed (come back) or is not responding to treatment - Your Wilms tumor was confirmed by tissue biopsy at the time of original diagnosis - You have already received at least 2 prior rounds of chemotherapy **You may NOT be eligible if...** - You have a history of a different cancer in the past 5 years - You received chemotherapy or radiation to the target lesion within the past 3 weeks - You are pregnant or breastfeeding - You have serious organ damage that would make chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVincristine

IV, D1-D22-D43 and D64

DRUGIrinotecan

Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)

DRUGTemozolomide

Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)

DRUGEtoposide

Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)

DRUGCis-Retinoic acid

Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)


Locations(18)

CHU Amiens Picardie

Amiens, France

CHU de Besancon

Besançon, France

CHRU de Bordeaux Hôpital des Enfants

Bordeaux, France

CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

Grenoble, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

Hôpital pour Enfants " La Timone " AP-HM

Marseille, France

CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

Montpellier, France

CHU Nantes

Nantes, France

CHU de Nice - Hôpital Archet 2

Nice, France

Hôpital Armand-TROUSSEAU

Paris, France

CHU Hôpital Sud

Rennes, France

Chu Rouen

Rouen, France

CHU La Réunion

Saint-Denis, France

CHRU Strasbourg - Hôpital de Hautepierre

Strasbourg, France

CHU Toulouse - Hôpital des Enfants

Toulouse, France

CHRU NANCY - Hôpital d'Enfants

Vandœuvre-lès-Nancy, France

Gustave ROUSSY

Villejuif, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05384821


Related Trials