Phase 1-2 Study of Metronomic Chemotherapy for Children and Teens With Relapsed or Hard-to-Treat Wilms Tumor

What this Trial Is About

Researchers are evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor. This interventional, non-randomized multicenter study aims to assess disease control after two cycles of metronomic chemotherapy. The study also focuses on progression-free survival, overall survival, early and best tumor response, safety, feasibility of treatment, and quality of life using the Kindl4 Quality of Life questionnaire at baseline and during treatment. Participants receive a combination of drugs including Vincristine, Irinotecan, Temozolomide, Etoposide, and Cis-Retinoic acid. Vincristine is administered intravenously on specific days, while the other drugs are given orally with varying schedules throughout each treatment cycle. The study treatment is delivered over multiple cycles, and the feasibility and safety of this metronomic chemotherapy regimen are closely evaluated. During the study, participants will undergo assessments such as tumor imaging to measure response, monitoring of adverse events, and quality of life questionnaires at designated weeks. Disease control is measured 6 months after inclusion, with follow-up for progression-free survival and overall survival extending to about one year. Safety is monitored throughout the study period plus 30 days, and feasibility of the therapy is assessed over the course of the study. Participants can expect regular visits and evaluations to track their health and response to treatment.

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)