Metronomic chemotherapy for relapsed Wilms tumor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Hélène SUDOUR-BONNANGE, MD — Centre Oscar Lambret
• Study coordinator: Emilie Heyman - Decoupigny
• Email: promotion@o-lambret.fr
• Phone: +33 (0)3 20 29 59 18

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.