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Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

ConditionWilms Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-17
SponsorCentre Oscar Lambret

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Vincristine

    Drug

    IV, D1-D22-D43 and D64

  • Irinotecan

    Drug

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

  • Temozolomide

    Drug

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

  • Etoposide

    Drug

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

  • Cis-Retinoic acid

    Drug

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

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acidExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Disease control

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 outcomes

1

Progression-free survival

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

Time frame
Up to progression, an average of 1 year
2

Overall survival

The time interval between study entry and death from any cause

Time frame
Through study completion, an average of 12 months
3

Tumor response

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
4

Adverse events

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Oscar Lambret

Lead sponsor

Source ClinicalTrials.gov
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