Actively Recruiting

Phase 1
Phase 2
Age: 18Months - 17Years
All Genders
NCT05384821

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Led by Centre Oscar Lambret · Updated on 2026-03-18

28

Participants Needed

18

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Who Can Participate

Age: 18Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 months old and 17 years old or younger
  • Histologically confirmed relapsed or refractory Wilms tumor
  • Received at least two lines of chemotherapy or one line for high risk relapse confirmed by coordinators
  • Radiologically measurable or evaluable disease on MRI or CT scan
  • Karnofsky performance status (patients >16 years) or Lansky Play score (patients 616 years) of at least 70%
  • Able to take oral medication or use nasal gastric tube or authorized gastrostomy
  • Adequate blood counts: neutrophils >1000/mm3, platelets >75,000/mm3
  • Liver enzymes (ALT/AST) less than or equal to 3 times upper limit of normal (or 6 times if liver metastasis), total bilirubin 62 times upper limit except Gilbert's disease
  • Creatinine less than or equal to 1.5 times upper limit or clearance at least 60 mL/min/1.73m2
  • Females of childbearing potential must have negative pregnancy test within 7 days before treatment
  • Sexually active patients agree to use effective contraception before, during, and after treatment
  • Written informed consent and age-appropriate assent obtained
  • Patient covered by French Social Security regime
Not Eligible

You will not qualify if you...

  • History of other cancer within 5 years
  • Chemotherapy or radiotherapy of target lesion within 3 weeks before inclusion
  • Targeted therapy within less than 5 half-lives before inclusion
  • Major surgery within 15 days before inclusion
  • Any grade 2 or higher cardiac, hepatic, pulmonary, or renal toxicity according to NCI-CTCAE v5
  • Severe myelosuppression
  • Severe peripheral neuropathy grade 2 or higher
  • Fructose intolerance
  • Chronic inflammatory bowel disease or intestinal obstruction
  • Demyelinating form of Charcot-Marie-Tooth disease
  • Known active viral hepatitis, HIV infection, or uncontrolled infection
  • Known hypersensitivity to dacarbazine, isotretinoin, or any trial drugs or excipients
  • Hyperlipidemia or hypervitaminosis A
  • Live attenuated vaccine within 1 month before inclusion
  • Pregnant or breastfeeding
  • Inability to comply with medical follow-up due to geographic, social, or psychological reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

CHU Amiens Picardie

Amiens, France, 80054

Not Yet Recruiting

2

CHU de Besancon

Besançon, France

Actively Recruiting

3

CHRU de Bordeaux Hôpital des Enfants

Bordeaux, France, 33076

Actively Recruiting

4

CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

Grenoble, France, 38043

Actively Recruiting

5

Centre Oscar Lambret

Lille, France, 59020

Actively Recruiting

6

Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

7

Hôpital pour Enfants " La Timone " AP-HM

Marseille, France, 13005

Actively Recruiting

8

CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

Montpellier, France, 34295

Not Yet Recruiting

9

CHU Nantes

Nantes, France, 44093

Actively Recruiting

10

CHU de Nice - Hôpital Archet 2

Nice, France, 06202

Actively Recruiting

11

Hôpital Armand-TROUSSEAU

Paris, France, 75012

Actively Recruiting

12

CHU Hôpital Sud

Rennes, France, 35203

Actively Recruiting

13

Chu Rouen

Rouen, France, 76000

Actively Recruiting

14

CHU La Réunion

Saint-Denis, France

Not Yet Recruiting

15

CHRU Strasbourg - Hôpital de Hautepierre

Strasbourg, France, 67098

Actively Recruiting

16

CHU Toulouse - Hôpital des Enfants

Toulouse, France, 70034

Actively Recruiting

17

CHRU NANCY - Hôpital d'Enfants

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

18

Gustave ROUSSY

Villejuif, France, 94805

Actively Recruiting

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Research Team

E

Emilie Heyman - Decoupigny

CONTACT

M

Marie Vanseymortier

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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