Kidney Cancer Clinical Trial

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

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 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.

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Full 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 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.

OUTLINE: Patients are assigned to 1 of 3 arms.

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.

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.

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.

VAD REGIMEN: Patients receive vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, 22, 29, and 36 (weeks 1-6) and dactinomycin IV and doxorubicin hydrochloride IV over 15-120 minutes on days 1 and 22 (weeks 1 and 4).

EE4A REGIMEN: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 22, 29, and 36 (weeks 1-6) and dactinomycin IV over 1-5 minutes on days 1 and 22 (weeks 1 and 4).

After completion of study treatment, patients are followed up periodically for 10 years.

View Eligibility Criteria

Eligibility 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)

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

249

Study ID:

NCT00945009

Recruitment Status:

Active, not recruiting

Sponsor:

Children's Oncology Group

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There are 162 Locations for this study

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Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Miller Children's and Women's Hospital Long Beach
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Valley Children's Hospital
Madera California, 93636, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
Children's Hospital of Orange County
Orange California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Rady Children's Hospital - San Diego
San Diego California, 92123, United States
UCSF Medical Center-Parnassus
San Francisco California, 94143, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
Broward Health Medical Center
Fort Lauderdale Florida, 33316, United States
Lee Memorial Health System
Fort Myers Florida, 33901, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Miami Cancer Institute
Miami Florida, 33176, United States
AdventHealth Orlando
Orlando Florida, 32803, United States
Arnold Palmer Hospital for Children
Orlando Florida, 32806, United States
Nemours Children's Clinic - Orlando
Orlando Florida, 32806, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola Florida, 32504, United States
Johns Hopkins All Children's Hospital
Saint Petersburg Florida, 33701, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States
Augusta University Medical Center
Augusta Georgia, 30912, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Norton Children's Hospital
Louisville Kentucky, 40202, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Scarborough Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Tufts Children's Hospital
Boston Massachusetts, 02111, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Kalamazoo Center for Medical Studies
Kalamazoo Michigan, 49008, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States
Nevada Cancer Research Foundation NCORP
Las Vegas Nevada, 89169, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Overlook Hospital
Summit New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
Mount Sinai Hospital
New York New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
Mission Hospital
Asheville North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Dayton Children's Hospital
Dayton Ohio, 45404, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo Ohio, 43606, United States
Mercy Children's Hospital
Toledo Ohio, 43608, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States
Greenville Cancer Treatment Center
Greenville South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo Texas, 79106, United States
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Cook Children's Medical Center
Fort Worth Texas, 76104, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
Covenant Children's Hospital
Lubbock Texas, 79410, United States
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Primary Children's Hospital
Salt Lake City Utah, 84113, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Charleston Division
Charleston West Virginia, 25304, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick New South Wales, 2031, Australia
The Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia
Royal Children's Hospital-Brisbane
Herston Queensland, 4029, Australia
Queensland Children's Hospital
South Brisbane Queensland, 4101, Australia
Women's and Children's Hospital-Adelaide
North Adelaide South Australia, 5006, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6008, Australia
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada
Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec , G1V 4, Canada
Schneider Children's Medical Center of Israel
Petah Tikua , 49202, Israel
Starship Children's Hospital
Grafton Auckland, 1145, New Zealand
Christchurch Hospital
Christchurch , 8011, New Zealand
San Jorge Children's Hospital
San Juan , 00912, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

249

Study ID:

NCT00945009

Recruitment Status:

Active, not recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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