Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Not Recruiting

Trial ID: NCT00945009


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 tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Official Title

Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Stanford Investigator(s)


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

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

   - No concurrent aprepitant


biological: dactinomycin

drug: doxorubicin hydrochloride

drug: vincristine sulfate

procedure: therapeutic conventional surgery

radiation: Radiation Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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