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Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Phase 1
Recruiting
Conditions
Wilms Tumor
Interventions
Registration Number
NCT05384821
Lead Sponsor
Centre Oscar Lambret
Brief Summary

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.

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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
28
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 study 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 study drug and for 6 months after stopping the study drug for both female and male patients.

  • Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures according to national guidelines.

  • Patient covered by the French "Social Security" regime

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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 study drugs, study 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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidCis-Retinoic acidMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidVincristineMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidIrinotecanMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidTemozolomideMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidEtoposideMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
Primary Outcome Measures
NameTimeMethod
Disease control6 months after inclusion

Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).

Secondary Outcome Measures
NameTimeMethod
Overall survivalThrough study completion, an average of 12 months

The time interval between study entry and death from any cause

Tumor responseImmediately after each cycle of treatment, up to progression, an average of 1 year

Using CT-scan or MRI imaging (using RECIST 1.1)

The feasibility of evaluated therapyThrough study completion, an average of 12 months

assessed in terms of frequency of dose reductions or temporary stops of treatment

Progression-free survivalUp to progression, an average of 1 year

The time interval between study entry and date of progression (using RECIST 1.1)

Adverse eventsThrough study completion, an average of 12 months (plus 30 days)

The adverse events (AE) are collected to evaluate the safety of the study treatment.

Quality of life of the patient (KindL)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

Trial Locations

Locations (16)

CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

🇫🇷

Montpellier, France

Centre Léon Bérard

🇫🇷

Lyon, France

CHRU NANCY - Hôpital d'Enfants

🇫🇷

Vandœuvre-lès-Nancy, France

CHU Nantes

🇫🇷

Nantes, France

Hôpital Armand-TROUSSEAU

🇫🇷

Paris, France

CHU Hôpital Sud

🇫🇷

Rennes, France

Chu Rouen

🇫🇷

Rouen, France

CHRU Strasbourg - Hôpital de Hautepierre

🇫🇷

Strasbourg, France

Hôpital pour Enfants " La Timone " AP-HM

🇫🇷

Marseille, France

CHU de Nice - Hôpital Archet 2

🇫🇷

Nice, France

Gustave ROUSSY

🇫🇷

Villejuif, France

CHU Toulouse - Hôpital des Enfants

🇫🇷

Toulouse, France

CHRU de Bordeaux Hôpital des Enfants

🇫🇷

Bordeaux, France

CHU Amiens Picardie

🇫🇷

Amiens, France

CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

🇫🇷

Grenoble, France

Centre Oscar Lambret

🇫🇷

Lille, France

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