Ireland
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Recruiting Phase 1/2

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

NCT05384821 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2022-09-14
Last updated
2026-03-18

Condition(s) studied

Wilms Tumor

Investigational drug(s) / intervention(s)

Vincristine →Irinotecan →Temozolomide →Etoposide →Cis-Retinoic acid

Vincristine: IV, D1-D22-D43 and D64

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

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

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

Cis-Retinoic acid: Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)

Study 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

Sex
ALL
Min age
18 Months
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • Disease control — 6 months after inclusion
    Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).

Trial sites (18)

FacilityCityRegionStatus
CHU Amiens Picardie Amiens France Not Yet Recruiting
CHU de Besancon Besançon France Recruiting
CHRU de Bordeaux Hôpital des Enfants Bordeaux France Recruiting
CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT Grenoble France Recruiting
Centre Oscar Lambret Lille France Recruiting
Centre Léon Bérard Lyon France Recruiting
Hôpital pour Enfants " La Timone " AP-HM Marseille France Recruiting
CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve Montpellier France Not Yet Recruiting
CHU Nantes Nantes France Recruiting
CHU de Nice - Hôpital Archet 2 Nice France Recruiting
Hôpital Armand-TROUSSEAU Paris France Recruiting
CHU Hôpital Sud Rennes France Recruiting
Chu Rouen Rouen France Recruiting
CHU La Réunion Saint-Denis France Not Yet Recruiting
CHRU Strasbourg - Hôpital de Hautepierre Strasbourg France Recruiting
CHU Toulouse - Hôpital des Enfants Toulouse France Recruiting
CHRU NANCY - Hôpital d'Enfants Vandœuvre-lès-Nancy France Recruiting
Gustave ROUSSY Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05384821 on ClinicalTrials.gov ↗ ← All trials in France