Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Recruiting now · Phase 1/Phase 2

Conditions studied: Wilms Tumor

In brief

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.

Key facts

Study ID

NCT05384821

Run by

Centre Oscar Lambret

People needed

28

Starts

2022-09-14

Expected to finish

2028-10-01

Last updated by the study team

2026-03-18

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥18 months old and ≤ 17 years old
• Relapsed or refractory Wilms tumor, histologically proven at diagnosis
• After at least 2 lines of chemotherapy (conventional or high dose, which may include the trial molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
• Radiologically measurable or evaluable disease (visible, target or non-target-lesion on MRI or CT-scan)
• Performance status: Karnofsky performance status (for patients >16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥ 70%.
• Able to take oral medication or nasal gastric tube or authorized gastrostomy
• Adequate biological criteria:
• Neutrophils > 1000/mm3 ; Platelets > 75 000/mm3
• Transaminases (ALT/ AST) ≤ 3 times ULN (or ≤ 6 times ULN if liver metastasis); total bilirubin ≤ 2 ULN (except in case of Gilbert's disease)
• Creatinine ≤ 1,5 ULN or clearance ≥ 60 mL/ min/ 1,73m2 (In case of doubt, to be confirm by assessment of cystatin )
• Females of childbearing potential must have a negative seric pregnancy test within 7 days prior to initiation of treatment.
• Sexually active patients must agree to use adequate and appropriate contraception (at least one highly effective contraception or two complementary methods of contraception), 1 month before beginning of treatment while on trial drug and for 7 months after stopping the trial drug for female patients and after 6 months for male patients.
• Written informed consent from parents/legal representative, patient, and age-appropriate assent before any trial-specific screening procedures according to national guidelines.
• Patient covered by the French "Social Security" regime

You may not qualify if…

• Prior history of other cancer within 5 years
• Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
• Target therapy within less than 5 * half-life of the substance prior to inclusion
• Major surgery within 15 days prior to inclusion
• Presence of any NCI-CTCAE v5 grade ≥ 2 cardiac, hepatic, pulmonary or renal toxicity
• Severe myelosuppression
• Severe peripheral neuropathy (grade ≥ 2)
• Fructose intolerance
• Inflammatory bowel chronic disease and/or intestinal obstruction
• Patients with demyelinating form of Charcot-Marie-Tooth disease
• Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
• Known hypersensitivity to dacarbazine (DTIC), isotretinoin or to any of the trial drugs, trial drug classes, excipients in the formulation
• Hyperlipidemia and hypervitaminosis A
• Vaccination with a live attenuated vaccine within 1 month prior to inclusion
• Pregnant or breastfeeding patients
• Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)

Where it is running

• Chu Rouen — Rouen, France (enrolling)
• CHRU Strasbourg - Hôpital de Hautepierre — Strasbourg, France (enrolling)
• CHU Toulouse - Hôpital des Enfants — Toulouse, France (enrolling)
• CHRU NANCY - Hôpital d'Enfants — Vandœuvre-lès-Nancy, France (enrolling)
• Gustave ROUSSY — Villejuif, France (enrolling)
• CHU de Nice - Hôpital Archet 2 — Nice, France (enrolling)
• Hôpital Armand-TROUSSEAU — Paris, France (enrolling)
• CHU Hôpital Sud — Rennes, France (enrolling)
• CHU de Besancon — Besançon, France (enrolling)
• CHRU de Bordeaux Hôpital des Enfants — Bordeaux, France (enrolling)
• CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT — Grenoble, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Hôpital pour Enfants " La Timone " AP-HM — Marseille, France (enrolling)
• CHU Nantes — Nantes, France (enrolling)
• CHU Amiens Picardie — Amiens, France
• CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve — Montpellier, France
• CHU La Réunion — Saint-Denis, France

Full record on ClinicalTrials.gov

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