Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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