A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Summary

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Conditions

• Anaplastic Kidney Wilms Tumor
• Recurrent Kidney Wilms Tumor
• Stage II Kidney Wilms Tumor
• Stage III Kidney Wilms Tumor
• Stage IV Kidney Wilms Tumor

Interventions

PROCEDURE

Biopsy Procedure

Undergo a biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo a bone scan

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Irinotecan

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo a PET scan

RADIATION

Radiation Therapy

Undergo RT

PROCEDURE

Surgical Procedure

Undergo surgery

DRUG

Topotecan

Given IV

PROCEDURE

Transabdominal Ultrasound

Undergo abdominal ultrasound

DRUG

Vincristine

Given IV

PROCEDURE

X-Ray Imaging

Undergo a chest x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• James I Geller · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2027-07-01

Completion

2027-07-01

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico
• Saudi Arabia

Study Locations