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OncoMatch/Clinical Trials/NCT05384821

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Is NCT05384821 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for wilms tumor.

Phase 1/2RecruitingCentre Oscar LambretNCT05384821Data as of May 2026

Treatment: Vincristine · Irinotecan · Temozolomide · Etoposide · Cis-Retinoic acidThis 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.

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Extracted eligibility criteria

Prior therapy

Min 2 prior lines

Must have received: chemotherapy

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.

Cannot have received: chemotherapy or radiotherapy of target lesion

Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion

Cannot have received: target therapy

Target therapy within less than 5 * half-life of the substance prior to inclusion

Lab requirements

Blood counts

Neutrophils > 1000/mm3; Platelets > 75,000/mm3

Kidney function

Creatinine ≤ 1.5 ULN or clearance ≥ 60 mL/min/1.73m2 (In case of doubt, to be confirm by assessment of cystatin)

Liver function

Transaminases (ALT/AST) ≤ 3 times ULN (or ≤ 6 times ULN if liver metastasis); total bilirubin ≤ 2 ULN (except in case of Gilbert's disease)

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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