Back to results

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (MetroWilms)

Primary Purpose

Wilms Tumor

Status

Recruiting

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Vincristine

Irinotecan

Temozolomide

Etoposide

Cis-Retinoic acid

About this trial

This is an interventional treatment trial for Wilms Tumor focused on measuring Multidrug chemotherapy, metronomic chemotherapy, Wilms Tumor, Renal cancer

Eligibility Criteria

18 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient ≥18 months old and ≤ 35 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

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)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid

Arm Description

Metronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid

Outcomes

Primary Outcome Measures

Disease control

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

Secondary Outcome Measures

Progression-free survival

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

Overall survival

The time interval between study entry and death from any cause

Tumor response

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

Adverse events

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

The feasibility of evaluated therapy

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

Quality of life of the patient (KindL)

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

Full Information

NCT ID

NCT05384821

First Posted

November 8, 2021

Last Updated

October 13, 2023

Sponsor

Centre Oscar Lambret

1. Study Identification

Unique Protocol Identification Number

NCT05384821

Brief Title

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Acronym

MetroWilms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2022 (Actual)

Primary Completion Date

May 2028 (Anticipated)

Study Completion Date

October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wilms Tumor

Keywords

Multidrug chemotherapy, metronomic chemotherapy, Wilms Tumor, Renal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid

Arm Type

Experimental

Arm Description

Metronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

IV, D1-D22-D43 and D64

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)

Intervention Type

Drug

Intervention Name(s)

Cis-Retinoic acid

Intervention Description

Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)

Primary Outcome Measure Information:

Title

Disease control

Description

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

Time Frame

6 months after inclusion

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

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

Time Frame

Up to progression, an average of 1 year

Title

Overall survival

Description

The time interval between study entry and death from any cause

Time Frame

Through study completion, an average of 12 months

Title

Tumor response

Description

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

Time Frame

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

Title

Adverse events

Description

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

Time Frame

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

Title

The feasibility of evaluated therapy

Description

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

Time Frame

Through study completion, an average of 12 months

Title

Quality of life of the patient (KindL)

Description

Time Frame

Baseline, week 7 and week 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emilie Heyman - Decoupigny

Phone

+33 (0)3 20 29 59 18

promotion@o-lambret.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Vanseymortier

Phone

+33 (0)3 20 29 59 18

promotion@o-lambret.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hélène SUDOUR-BONNANGE, MD

Organizational Affiliation

Centre Oscar Lambret

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arnauld VERSCHUUR, MD, PhD

Organizational Affiliation

CHU La Timone

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens Picardie

City

Amiens

ZIP/Postal Code

80054

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leslie ANDRY, MD

Phone

+33 3 22 08 76 44

andry.leslie@chu-amiens.fr

First Name & Middle Initial & Last Name & Degree

Leslie ANDRY, MD

Facility Name

CHRU de Bordeaux Hôpital des Enfants

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne NOTZ- CARRERE, MD

Phone

+33 5 57 82 04 34

anne.notz-carrere@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Anne NOTZ- CARRERE, MD

Facility Name

CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominique PLANTAZ, MD

Phone

+33 4 76 76 59 11

DPlantaz@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Dominique PLANTAZ, MD

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène SUDOUR-BONNANGE, MD

Phone

+33 3 20 29 59 56

h-sudour@o-lambret.fr

First Name & Middle Initial & Last Name & Degree

Cyril LERVAT, MD

Phone

+33 3 20 29 59 56

c-lervat@o-lambret.fr

First Name & Middle Initial & Last Name & Degree

Hélène SUDOUR-BONNANGE, MD

First Name & Middle Initial & Last Name & Degree

Cyril LERVAT, MD

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69373

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit DUMONT, MD

Phone

+33 4 69 16 65 74

Benoit.DUMONT@ihope.fr

First Name & Middle Initial & Last Name & Degree

Benoit DUMONT, MD

Facility Name

Hôpital pour Enfants " La Timone " AP-HM

City

Marseille

ZIP/Postal Code

13005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnauld VERSCHUUR, MD

Phone

+33 4 91 38 86 21

arnauld.verschuur@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

Arnauld Verschuur, MD

Facility Name

CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphanie HAOUY, MD

Phone

+33 4 67 33 65 19

s-haouy@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Stéphanie HAOUY, MD

Facility Name

CHU Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Estelle THEBAUD, MD

Phone

+33 2 40 08 36 10

Estelle.THEBAUD@chu-nantes.fr

First Name & Middle Initial & Last Name & Degree

Estelle THEBAUD, MD

Facility Name

CHU de Nice - Hôpital Archet 2

City

Nice

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joy BENADIBA, MD

Phone

+33 4 92 03 92 68

benadiba.j@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Joy BENADIBA, MD

Facility Name

Hôpital Armand-TROUSSEAU

City

Paris

ZIP/Postal Code

75012

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie Dominique TABONE, MD

Phone

+33 1 44 73 68 46

marie-dominique.tabone@aphp.fr

First Name & Middle Initial & Last Name & Degree

Marie Dominique TABONE, MD

Facility Name

CHU Hôpital Sud

City

Rennes

ZIP/Postal Code

35203

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacinthe BONNEAU-LAGACHERIE, MD

Phone

+33 2 99 26 59 17

Jacinthe.BONNEAU-LAGACHERIE@chu-rennes.fr

First Name & Middle Initial & Last Name & Degree

Jacinthe BONNEAU-LAGACHERIE, MD

Facility Name

Chu Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aude MARIE-CARDINE, MD

Phone

+33 2 32 88 81 91

Aude.Marie-Cardine@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Aude MARIE-CARDINE, MD

Facility Name

CHRU Strasbourg - Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah JANNIER, MD

Phone

+33 3 88 12 87 94

sarah.jannier@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Sarah JANNIER, MD

Facility Name

CHU Toulouse - Hôpital des Enfants

City

Toulouse

ZIP/Postal Code

70034

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cécile BOULANGER, MD

Phone

+33 5 34 55 75 66

boulanger.c@chu-toulouse.fr

First Name & Middle Initial & Last Name & Degree

Cécile BOULANGER, MD

Facility Name

CHRU NANCY - Hôpital d'Enfants

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

54500

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ludovic MANSUY, MD

Phone

+33 3 83 15 47 34

lu.mansuy@chru-nancy.fr

First Name & Middle Initial & Last Name & Degree

Ludovic MANSUY, MD

Facility Name

Gustave ROUSSY

City

Villejuif

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudia PASQUALINI, MD

Phone

+33 1 42 11 42 11

Claudia.pasqualini@gustaveroussy.fr

First Name & Middle Initial & Last Name & Degree

Claudia PASQUALINI, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

We'll reach out to this number within 24 hrs

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (MetroWilms)

Wilms Tumor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial