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Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | N/A - 29 Years |
| Gender | All |
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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00945009 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Peter F Ehrlich |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, Israel, New Zealand, Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Adult Kidney Wilms Tumor, Beckwith-Wiedemann Syndrome, Childhood Kidney Wilms Tumor, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Rhabdoid Tumor of the Kidney, Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor, Stage V Kidney Wilms Tumor |
| Study Website: | View Trial Website |
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 BWT by using prenephrectomy 3-drug chemotherapy induction with vincristine (vincristine sulfate), dactinomycin, and doxorubicin (doxorubicin hydrochloride).
- III. To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.
- IV. To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.
- V. To have 75% of patients with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy.
Arms
Experimental: Arm 1 (Bilateral Wilms Tumors)
Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.
Experimental: Arm 2 (Unilateral High Risk tumors bilaterally predisposed)
Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.
Experimental: Arm 3 (DHPLN)
Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.
Interventions
Biological: - Dactinomycin
Given IV
Drug: - Doxorubicin Hydrochloride
Given IV
Radiation: - Radiation Therapy
Undergo radiation therapy
Procedure: - Therapeutic Conventional Surgery
Undergo surgical resection
Drug: - Vincristine Sulfate
Given IV
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
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Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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Banner University Medical Center - Tucson
Tucson, Arizona, 85719
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
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Kaiser Permanente Downey Medical Center
Downey, California, 90242
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Loma Linda University Medical Center
Loma Linda, California, 92354
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Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
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Children's Hospital Los Angeles
Los Angeles, California, 90027
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Valley Children's Hospital
Madera, California, 93636
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UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
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Kaiser Permanente-Oakland
Oakland, California, 94611
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Children's Hospital of Orange County
Orange, California, 92868
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Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
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Rady Children's Hospital - San Diego
San Diego, California, 92123
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UCSF Medical Center-Parnassus
San Francisco, California, 94143
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UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Children's Hospital Colorado
Aurora, Colorado, 80045
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Address
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
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Children's National Medical Center
Washington, District of Columbia, 20010
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Broward Health Medical Center
Fort Lauderdale, Florida, 33316
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Address
Lee Memorial Health System
Fort Myers, Florida, 33901
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
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Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
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Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
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Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Miami Cancer Institute
Miami, Florida, 33176
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AdventHealth Orlando
Orlando, Florida, 32803
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Arnold Palmer Hospital for Children
Orlando, Florida, 32806
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Address
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
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Address
Orlando Health Cancer Institute
Orlando, Florida, 32806
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Nemours Children's Hospital
Orlando, Florida, 32827
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Address
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
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Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
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Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
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Saint Mary's Medical Center
West Palm Beach, Florida, 33407
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Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
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Address
Augusta University Medical Center
Augusta, Georgia, 30912
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Address
Memorial Health University Medical Center
Savannah, Georgia, 31404
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Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
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Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
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Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
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Riley Hospital for Children
Indianapolis, Indiana, 46202
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Blank Children's Hospital
Des Moines, Iowa, 50309
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Address
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
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Address
Norton Children's Hospital
Louisville, Kentucky, 40202
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Address
Tulane University School of Medicine
New Orleans, Louisiana, 70112
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Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
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Address
Eastern Maine Medical Center
Bangor, Maine, 04401
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Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
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Address
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
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Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
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Address
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
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Address
Tufts Children's Hospital
Boston, Massachusetts, 02111
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Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
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Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
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Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
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Address
Michigan State University Clinical Center
East Lansing, Michigan, 48824
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Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
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Address
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
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Address
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
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Address
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
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Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
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Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Address
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
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Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
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Address
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
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Address
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89169
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Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
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Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Saint Barnabas Medical Center
Livingston, New Jersey, 07039
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Morristown Medical Center
Morristown, New Jersey, 07960
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Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
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Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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Overlook Hospital
Summit, New Jersey, 07902
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Address
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
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Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
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Address
NYU Langone Hospital - Long Island
Mineola, New York, 11501
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Mount Sinai Hospital
New York, New York, 10029
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Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
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Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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Address
University of Rochester
Rochester, New York, 14642
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Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
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Address
Mission Hospital
Asheville, North Carolina, 28801
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Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
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Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
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Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
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Duke University Medical Center
Durham, North Carolina, 27710
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Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
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Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
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Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
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Address
Dayton Children's Hospital
Dayton, Ohio, 45404
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Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
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Mercy Children's Hospital
Toledo, Ohio, 43608
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Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
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Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
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Address
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
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Penn State Children's Hospital
Hershey, Pennsylvania, 17033
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
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Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
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Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
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Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
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Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
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Address
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605
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Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
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East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
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Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
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Address
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106
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Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
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Address
Medical City Dallas Hospital
Dallas, Texas, 75230
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Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
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Address
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
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Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
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Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
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Address
Covenant Children's Hospital
Lubbock, Texas, 79410
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Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
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Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
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Address
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
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Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Status
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
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Address
Seattle Children's Hospital
Seattle, Washington, 98105
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Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
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Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
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Address
Madigan Army Medical Center
Tacoma, Washington, 98431
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Address
West Virginia University Charleston Division
Charleston, West Virginia, 25304
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Address
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
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Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
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Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
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Sydney Children's Hospital
Randwick, New South Wales, 2031
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The Children's Hospital at Westmead
Westmead, New South Wales, 2145
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Address
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
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Address
Royal Children's Hospital-Brisbane
Herston, Queensland, 4029
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Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
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Address
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006
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Address
Princess Margaret Hospital for Children
Perth, Western Australia, 6008
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Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
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Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
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Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
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Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
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Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
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Address
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Status
Address
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
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Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Status
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Status
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
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Address
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
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Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
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Address
Schneider Children's Medical Center of Israel
Petah Tikua, , 49202
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Address
Starship Children's Hospital
Grafton, Auckland, 1145
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Christchurch Hospital
Christchurch, , 8011
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Address
San Jorge Children's Hospital
San Juan, , 00912
