Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (MetroWilms)

March 16, 2026 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main aim of this study is to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy .

Other objectives of the study include:

  • To evaluate disease control obtained with metronomic chemotherapy, in terms of progression-free survival (PFS) and overall survival (OS).
  • Evaluating early response after one cycle of treatment of metronomic treatment;
  • Evaluating best tumor response over the whole metronomic treatment duration;
  • Evaluating safety of the proposed metronomic chemotherapy;
  • Evaluating the feasibility of the proposed metronomic chemotherapy.
  • To evaluate quality of life using Kindl® Quality of Life questionnaire at baseline (before start of treatment), and approximately at weeks 7 and 13 of treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens Picardie
        • Contact:
        • Principal Investigator:
          • Leslie ANDRY, MD
      • Besançon, France
        • Recruiting
        • CHU de Besançon
        • Principal Investigator:
          • Véronique LAITHIER, MD
        • Contact:
      • Bordeaux, France, 33076
        • Recruiting
        • CHRU de Bordeaux Hôpital des Enfants
        • Contact:
        • Principal Investigator:
          • Anne NOTZ- CARRERE, MD
      • Grenoble, France, 38043
        • Recruiting
        • CHU Grenoble Alpes - Hopital Couple Enfant
        • Principal Investigator:
          • Dominique PLANTAZ, MD
        • Contact:
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hélène SUDOUR-BONNANGE, MD
        • Principal Investigator:
          • Cyril LERVAT, MD
      • Lyon, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Contact:
        • Principal Investigator:
          • Benoit DUMONT, MD
      • Marseille, France, 13005
        • Recruiting
        • Hôpital pour Enfants " La Timone " AP-HM
        • Contact:
        • Principal Investigator:
          • Arnauld Verschuur, MD
      • Montpellier, France, 34295
        • Not yet recruiting
        • CHU de Montpellier - Hôpital Arnaud de Villeneuve
        • Contact:
        • Principal Investigator:
          • Stéphanie HAOUY, MD
      • Nantes, France, 44093
        • Recruiting
        • CHU Nantes
        • Contact:
        • Principal Investigator:
          • Estelle THEBAUD, MD
      • Nice, France, 06202
        • Recruiting
        • CHU de Nice - Hôpital Archet 2
        • Contact:
        • Principal Investigator:
          • Joy BENADIBA, MD
      • Paris, France, 75012
        • Recruiting
        • Hôpital Armand-Trousseau
        • Contact:
        • Principal Investigator:
          • Marie Dominique TABONE, MD
      • Rennes, France, 35203
        • Recruiting
        • CHU Hopital Sud
        • Contact:
        • Principal Investigator:
          • Jacinthe BONNEAU-LAGACHERIE, MD
      • Rouen, France, 76000
        • Recruiting
        • CHU Rouen
        • Contact:
        • Principal Investigator:
          • Aude MARIE-CARDINE, MD
      • Saint-Denis, France
        • Not yet recruiting
        • CHU La Réunion
        • Principal Investigator:
          • Yves REGUERRE, MD
        • Contact:
      • Strasbourg, France, 67098
        • Recruiting
        • CHRU Strasbourg - Hôpital de Hautepierre
        • Principal Investigator:
          • Sarah JANNIER, MD
        • Contact:
      • Toulouse, France, 70034
        • Recruiting
        • CHU Toulouse - Hopital des enfants
        • Principal Investigator:
          • Cécile BOULANGER, MD
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • CHRU NANCY - Hôpital d'Enfants
        • Principal Investigator:
          • Ludovic MANSUY, MD
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
        • Contact:
        • Principal Investigator:
          • Claudia PASQUALINI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Metronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Drug: Vincristine
IV, D1-D22-D43 and D64
Drug: Irinotecan
Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)
Drug: Temozolomide
Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)
Drug: Etoposide
Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)
Drug: Cis-Retinoic acid
Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control
Time Frame: 6 months after inclusion
Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to progression, an average of 1 year
The time interval between study entry and date of progression (using RECIST 1.1)
Up to progression, an average of 1 year
Overall survival
Time Frame: Through study completion, an average of 12 months
The time interval between study entry and death from any cause
Through study completion, an average of 12 months
Tumor response
Time Frame: Immediately after each cycle of treatment, up to progression, an average of 1 year
Using CT-scan or MRI imaging (using RECIST 1.1)
Immediately after each cycle of treatment, up to progression, an average of 1 year
Adverse events
Time Frame: Through study completion, an average of 12 months (plus 30 days)
The adverse events (AE) are collected to evaluate the safety of the study treatment.
Through study completion, an average of 12 months (plus 30 days)
The feasibility of evaluated therapy
Time Frame: Through study completion, an average of 12 months
assessed in terms of frequency of dose reductions or temporary stops of treatment
Through study completion, an average of 12 months
Quality of life of the patient (KindL)
Time Frame: Baseline, week 7 and week 13
Ravens-Sieberer and Bullinger Quality of Life Questionnaire will be used to measure the quality of life of the patients. The score can go from 0 to 100, and the higher score corresponds to a higher health-related quality of life
Baseline, week 7 and week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Hélène SUDOUR-BONNANGE, MD, Centre Oscar Lambret
  • Principal Investigator: Arnauld VERSCHUUR, MD, PhD, CHU La Timone

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MetroWilms-1906
  • PHRC-K22-018 (Other Grant/Funding Number: DGOS/INCA)
  • 2022-502687-20-00 (Ctis)
  • 2021-002540-67 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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