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New chemo cocktail aims to tame tough childhood kidney cancer

NCT ID NCT05384821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of five chemotherapy drugs given in a low-dose, frequent schedule (metronomic chemo) for children aged 1.5 to 17 years whose Wilms tumor has returned or not responded to at least two prior treatments. The goal is to see if this approach can stop the tumor from growing after two cycles. The trial is currently recruiting 28 participants across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
combination chemotherapy (vincristine, irinotecan, temozolomide, etoposide, cis-retinoic acid)
What this could lead to
If it works, this could offer a new treatment option to control Wilms tumor that has come back or not responded to standard therapy.
What could go wrong
This is an early-phase trial with only 28 participants, so results may not apply broadly. The combination of drugs may cause significant side effects and may not control the tumor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU NANCY - Hôpital d'Enfants

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • CHRU Strasbourg - Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • CHRU de Bordeaux Hôpital des Enfants

    RECRUITING

    Bordeaux, 33076, France

  • CHU Amiens Picardie

    NOT_YET_RECRUITING

    Amiens, 80054, France

  • CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

    RECRUITING

    Grenoble, 38043, France

  • CHU Hôpital Sud

    RECRUITING

    Rennes, 35203, France

  • CHU La Réunion

    NOT_YET_RECRUITING

    Saint-Denis, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU Toulouse - Hôpital des Enfants

    RECRUITING

    Toulouse, 70034, France

  • CHU de Besancon

    RECRUITING

    Besançon, France

  • CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • CHU de Nice - Hôpital Archet 2

    RECRUITING

    Nice, 06202, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Chu Rouen

    RECRUITING

    Rouen, 76000, France

  • Gustave ROUSSY

    RECRUITING

    Villejuif, 94805, France

  • Hôpital Armand-TROUSSEAU

    RECRUITING

    Paris, 75012, France

  • Hôpital pour Enfants " La Timone " AP-HM

    RECRUITING

    Marseille, 13005, France

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