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Metronomic chemotherapy for relapsed Wilms tumor

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

Phase1; Phase2 Interventional Centre Oscar Lambret · NCT05384821

This study is testing a new low-dose chemotherapy treatment for kids with relapsed Wilms tumor to see if it helps control their disease better than previous treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment28 (estimated)
Ages18 Months to 17 Years
SexAll
SponsorCentre Oscar Lambret Academic / other
Drugs / interventionschemotherapy
Locations18 sites (Amiens and 17 other locations)
Trial IDNCT05384821 on ClinicalTrials.gov

What this trial studies

This multicenter, interventional study evaluates the efficacy of metronomic chemotherapy in patients with relapsed or refractory Wilms tumor. Participants will receive a regimen including Vincristine, Irinotecan, Temozolomide, Etoposide, and Cis-Retinoic acid, with the primary goal of assessing disease control after two cycles of treatment. The study will also measure progression-free survival, overall survival, safety, and quality of life at various points during the treatment. The approach aims to provide a continuous low-dose chemotherapy option for patients who have not responded to previous treatments.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 months to 17 years with relapsed or refractory Wilms tumor who have undergone at least two lines of chemotherapy.

Not a fit: Patients with Wilms tumor who have not experienced relapse or those who are not eligible for further chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease control and overall survival for patients with relapsed Wilms tumor.

How similar studies have performed: While metronomic chemotherapy has been explored in other contexts, this specific application in Wilms tumor is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Amiens and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Wilms TumorMultidrug chemotherapymetronomic chemotherapyRenal cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.