Status:
ACTIVE_NOT_RECRUITING
Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Kidney Wilms Tumor
Beckwith-Wiedemann Syndrome
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE3
Brief Summary
This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tum...
Detailed Description
OBJECTIVES: I. To improve 4-year event-free survival (EFS) to 73% for young patients with bilateral Wilms tumor (BWT). II. To prevent complete removal of at least one kidney in 50% of patients with ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The patient must have one of the following conditions to be eligible:
- Synchronous bilateral Wilms tumors\*\*; or
- Unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel-Syndrome, Denys-Drash Syndrome or other associated genitourinary anomalies associated with bilateral Wilms tumor, such as hypospadias and undescended testis (to be eligible, these patients must not undergo any nephrectomy at diagnosis; note-horseshoe kidney is not associated with bilateral Wilms tumor and these patients should go on the appropriate unilateral Wilms tumor study); or
- Multicentric Wilms tumor (any age) (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
- Unilateral Wilms tumor with contralateral nephrogenic rest(s) (any size) in a child under one year of age (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
- Diffuse hyperplastic perilobar nephroblastomatosis (unilateral or bilateral) defined by central radiological review; or
- Wilms tumor arising in a solitary kidney (patients with metachronous Wilms tumor are not eligible)
- The AREN0534 study uses the guideline that Wilms tumor with a single lesion 1 cm or greater in the contralateral kidney or multiple lesions (of any size) in the contralateral kidney should be treated on the synchronous bilateral Wilms tumor stratum; patients with an isolated lesion less than 1 cm in the contralateral kidney should be treated on the appropriate study for unilateral Wilms tumor OR on the unilateral Wilms tumor/contralateral nephrogenic rest stratum of this study if they have not undergone nephrectomy and are under one year of age
- Loss of heterozygosity (LOH) results-which are used in the unilateral Wilms tumor studies-are not a requirement for enrollment on AREN0534; blood samples can be submitted but will not be used to direct AREN0534 therapy
- Specimens/materials must be submitted for central review by day 7; for enrollment on AREN0534, unless a biopsy was done, the submission requirements at enrollment on AREN03B2 refer to imaging studies; tissue samples are only required if a surgical procedure (biopsy or nephrectomy) was performed at the time of enrollment on AREN03B2
- Patients must begin protocol therapy on AREN0534 by day 14 following surgery or diagnosis by initial computed tomography (CT)/magnetic resonance imaging (MRI), unless medically contraindicated
- Karnofsky performance status must be \>= 50% for patients \> 16 years of age and Lansky performance status must be \>= 50% (for patients =\< 16 years of age
- Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study
- Patients with unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel-Syndrome, Denys-Drash Syndrome or other associated genitourinary anomalies; or multicentric or unilateral Wilms tumor with contralateral nephrogenic rest(s) (any size) in a child under 1 year of age who undergo a nephrectomy at diagnosis are not eligible for this study and should be directed to a unilateral Wilms tumor study
- Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 times upper limit of normal (ULN) for age
- Shortening fraction \>= 27% by echocardiogram, OR ejection fraction \>= 50% by radionuclide angiogram
- (Cardiac function does not need to be assessed in patients who will not receive doxorubicin as part of their initial therapy on this study \[i.e., patients who start on regimen EE-4A\])
- Female patients of childbearing age must have a negative pregnancy test
- Female patients who are lactating must agree to stop breastfeeding
- Sexually active patients of childbearing potential must agree to use effective contraception
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
- No concurrent aprepitant
Exclusion
Key Trial Info
Start Date :
July 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00945009
Start Date
July 13 2009
Last Update
May 31 2025
Active Locations (169)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719