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AREN1921: Combination Chemotherapy for Wilms Tumors

About this study

This clinical trial will test a new way of treating children and young adults who have 2 types of Wilms tumors:

  • Diffuse anaplastic Wilms tumors (DAWT): These tumors have cells that appear very abnormal under the microscope and are spread throughout the tumor. This trial will focus on treating DAWT upfront, meaning as part of the initial treatment phase.
  • Favorable histology Wilms tumors (FHWT) that have relapsed: These tumors have cells that look less abnormal under the microscope but have returned after previous treatment.

We will treat patients based on the type of Wilms tumor they have, the treatment they have received in the past, and the risk for their tumor coming back. They will be put in 1 of 2 treatment groups: UH-3 or ICE/CYCLO/TOPO:

UH-3

Patients with DAWT or FHWT with moderate (standard) risk for relapse will get chemotherapy and radiation therapy to kill and slow tumor growth.

They will get these chemotherapy medicines:

After cycle 2, patients will also get imaging scans, biopsies, and blood tests. They will get radiation therapy after their 3rd cycle of treatment as needed. Patients will receive a total of 14 cycles of treatment.

ICE/CYCLO/TOPO

Patients with FHWT tumors that are high or very high risk for relapse will get chemotherapy and radiation therapy to kill and slow tumor growth, and in some cases, surgery to remove the tumors.

We will use a combination of 5 chemotherapy medicines: ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan. Different combinations of these treatments will be given at different times:

  • Ifosfamide, carboplatin, and etoposide (ICE) in cycles 1, 2, 4, 5, and 7
  • Cyclophosphamide and topotecan in cycles 3, 6, 8, and 10

These treatments will be given in 3 cycles that last 3 weeks. Afterward, patients will have imaging studies to see if the tumor has changed. If the tumor has not gotten larger and the patient can tolerate the treatment without bad side effects, they will continue to get more treatment cycles. After cycle 6, we will do imaging studies of their tumor again. Patients will get up to 10 cycles of treatment.

Patients in this treatment group will also have imaging scans, biopsies, and blood tests during the trial.

Patients in this clinical trial will be followed for up to 5 years.

The chemotherapy medicines ICE and cyclophosphamide/topotecan have been used to treat patients before, but this is the first time these medicines will be used together for children and young adults.

Eligibility overview

  • Diffuse anaplastic Wilms tumor enrolled in APEC14B1
  • Relapsed favorable histology Wilms tumor
  • Up to age 30

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

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

Study goal:

To study if combination chemotherapy with ICE/Cyclo/Topo is safe and effective for people with diffuse anaplastic Wilms tumor and with high-risk or very-high risk relapsed favorable histology Wilms tumor. 

Diagnosis:

Wilms tumor

Age:

Up to 30 years

Clinical trials categories:

Childhood Cancer Wilms Tumor

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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