A Phase II Study of Combination Chemotherapy, Surgery, and Radiation Therapy for Patients with High-Risk Wilms' Tumors

Full Title

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT) (AREN1921) (CIRB)

Purpose

This study is evaluating the safety and effectiveness of combination chemotherapy, surgery, and radiation therapy in children and young adults with newly diagnosed stage II-IV diffuse anaplastic Wilms’ tumors (DAWT) or favorable histology Wilms’ tumors (FHWT) that have come back (relapsed).

Patients with newly diagnosed stage II-IV DAWT or FHWT that relapsed after initial treatment with 2 chemotherapy drugs will receive a drug combination called UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan), in addition to surgery and radiation. Patients with FHWT that relapses after 3 or more chemotherapy drugs will receive the ICE/Cyclo/Topo chemotherapy regimen (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan), in addition to surgery and radiation.

All of these medications are given intravenously (by vein). Doctors hope the results of this study will help them choose the most effective treatment for patients with different types of high-risk Wilms’ tumors.

Protocol
20-512
Phase
Phase II (phase 2)
Investigator
ClinicalTrials.gov ID
NCT04322318