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

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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.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed stage II-IV DAWT or FHWT in first relapse.
  • Patients who received prior treatment must recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 30 and younger.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

20-512

Phase

II

Investigator