Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

This study has suspended participant recruitment.
(Temporarily stopped for assessment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00945009
First received: July 22, 2009
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Bilateral Wilms tumor and children who are a special risk for forming tumors in both kidneys. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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.


Condition Intervention Phase
Adult Renal Wilms Tumor
Beckwith-Wiedemann Syndrome
Childhood Renal Wilms Tumor
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Hemihypertrophy
Stage I Renal Wilms Tumor
Stage II Renal Wilms Tumor
Stage III Renal Wilms Tumor
Stage IV Renal Wilms Tumor
Stage V Renal Wilms Tumor
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Etoposide Phosphate
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Procedure: Adjuvant Therapy
Procedure: Neoadjuvant Therapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Efficacy of chemotherapy in preserving renal units and preventing Wilms tumor development in patients with diffuse hyperplastic perilobular nephrogenic rests [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Facilitation of partial nephrectomy in lieu of total nephrectomy in 25% of patients with unilateral Wilms tumor [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with bilateral Wilms tumor (BWT) undergoing definitive surgical treatment by week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: July 2009
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, radiation therapy, surgery)
See Detailed Description
Biological: Dactinomycin
Given IV
Other Name: Lyovac Cosmegen
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Carboplatin
Given IV
Drug: Cyclophosphamide
Given IV
Drug: Etoposide Phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Procedure: Therapeutic Conventional Surgery
Undergo surgical resection
Procedure: Adjuvant Therapy
Undergo adjuvant therapy
Other Name: Adjuvant Therapy
Procedure: Neoadjuvant Therapy
Undergo neoadjuvant therapy
Other Names:
  • Induction Therapy
  • induction therapy
  • Neoadjuvant
  • Neoadjuvant Therapy
  • Preoperative Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
    • It is often difficult to distinguish Wilms tumors from nephrogenic rests based on imaging studies and percutaneous biopsies. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945009

  Show 152 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Peter Ehrlich, MD MSC Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00945009     History of Changes
Other Study ID Numbers: AREN0534, NCI-2011-01953, CDR0000649716, AREN0534, AREN0534, U10CA180886, U10CA098543
Study First Received: July 22, 2009
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Beckwith-Wiedemann Syndrome
Hyperplasia
Neoplasms
Wilms Tumor
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Pathologic Processes
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Dactinomycin
Doxorubicin
Etoposide
Etoposide phosphate
Liposomal doxorubicin
Vincristine
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 19, 2015