Informations générales (source: ClinicalTrials.gov)
Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor
Interventional
Phase 1/Phase 2
Centre Oscar Lambret (Voir sur ClinicalTrials)
septembre 2022
octobre 2028
13 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Marie Dominique TABONE, MD | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Claudia PASQUALINI, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69373 - Lyon - France | Benoit DUMONT, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Hélène SUDOUR-BONNANGE, MD | Contact (sur clinicalTrials) | |||
| CHRU de Bordeaux Hôpital des Enfants - 33076 - Bordeaux - France | Anne NOTZ- CARRERE, MD | Contact (sur clinicalTrials) | |||
| CHRU NANCY - Hôpital d'Enfants - 54500 - Vandœuvre-lès-Nancy - France | Ludovic MANSUY, MD | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg - Hôpital de Hautepierre - 67098 - Strasbourg - France | Sarah JANNIER, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie - 80054 - Amiens - France | Leslie ANDRY, MD | Contact (sur clinicalTrials) | |||
| CHU de Besancon - Besançon - France | Véronique LAITHIER, MD | Contact (sur clinicalTrials) | |||
| CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve - 34295 - Montpellier - France | Stéphanie HAOUY, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Hôpital Archet 2 - 06202 - Nice - France | Joy BENADIBA, MD | Contact (sur clinicalTrials) | |||
| CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT - 38043 - Grenoble - France | Dominique PLANTAZ, MD | Contact (sur clinicalTrials) | |||
| CHU Hôpital Sud - 35203 - Rennes - France | Jacinthe BONNEAU-LAGACHERIE, MD | Contact (sur clinicalTrials) | |||
| CHU La Réunion - Saint-Denis - France | Yves REGUERRE | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44093 - Nantes - France | Estelle THEBAUD, MD | Contact (sur clinicalTrials) | |||
| Chu Rouen - 76000 - Rouen - France | Aude MARIE-CARDINE, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Hôpital des Enfants - 70034 - Toulouse - France | Cécile BOULANGER, MD | Contact (sur clinicalTrials) | |||
| Hôpital pour Enfants " La Timone " AP-HM - 13005 - Marseille - France | Arnauld VERSCHUUR, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)