Kidney Cancer Clinical Trial

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms’ Tumor

Summary

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

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Full Description

PRIMARY OBJECTIVES:

I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride.

II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M).

III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M.

SECONDARY OBJECTIVES:

I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor.

OUTLINE: This is a multicenter study.

REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25).

All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases) proceed to regimen M (weeks 7-31).

Patients with initially unresectable or incompletely resected tumors are reevaluated at week 6, and if resectable, undergo surgery and then proceed to either regimen DD4A or regimen M as described above.

REGIMEN DD4A (weeks 7-25): Patients receive dactinomycin IV over 1-5 minutes once in weeks 7, 13, 19, and 25; vincristine IV once in weeks 7-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes once in weeks 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.

REGIMEN M (weeks 7-31): Patients receive cyclophosphamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 7, 10, 19, and 25; vincristine IV once in weeks 8, 9, 11, 12, 13, 16, 22, 28, and 31; and dactinomycin IV and doxorubicin hydrochloride IV over 15 minutes once in weeks 13, 16, 22, 28, and 31 in the absence of disease progression or unacceptable toxicity. Patients with pulmonary metastases only who are SIR also undergo whole lung radiotherapy once daily beginning in week 7 and continuing for 5-14 days.

NOTE: Patients who begin study treatment after undergoing resection of pulmonary metastases are treated according to regimen DD4A (weeks 1-25) and undergo whole lung radiotherapy for 5-14 days beginning in week 1.

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed Wilms' tumor meeting 1 of the following criteria:

Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
Patients must begin therapy within 14 days after surgery or biopsy, unless medically contraindicated

No bilateral Wilms' tumors (stage IV)

Patients should be referred to COG-AREN0534
Previously enrolled in clinical trial COG-AREN03B2
Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT < 2.5 times ULN
Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
No concurrent aprepitant

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

395

Study ID:

NCT00379340

Recruitment Status:

Active, not recruiting

Sponsor:

Children's Oncology Group

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There are 211 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
USA Health Strada Patient Care Center
Mobile Alabama, 36604, 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
Cedars Sinai Medical Center
Los Angeles California, 90048, 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
Sutter Medical Center Sacramento
Sacramento California, 95816, 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
University of Connecticut
Farmington Connecticut, 06030, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Yale University
New Haven Connecticut, 06520, 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
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, 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
Nicklaus Children's Hospital
Miami Florida, 33155, 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 Clinic - Pensacola
Pensacola Florida, 32504, United States
Sacred Heart Hospital
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
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge
Park Ridge Illinois, 60068, United States
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis Indiana, 46260, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, 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
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Tufts Children's Hospital
Boston Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
UMass Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, 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
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Kalamazoo Center for Medical Studies
Kalamazoo Michigan, 49008, United States
Beaumont Children's Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, 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
Columbia Regional
Columbia Missouri, 65201, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia Missouri, 65212, United States
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, 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
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
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States
Overlook Hospital
Summit New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Albany Medical Center
Albany New York, 12208, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Brooklyn Hospital Center
Brooklyn New York, 11201, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, 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
NYP/Weill Cornell Medical Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
New York Medical College
Valhalla New York, 10595, 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
East Carolina University
Greenville North Carolina, 27834, 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 Toledo
Toledo Ohio, 43614, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa Oklahoma, 74136, United States
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Oncology Group
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
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, 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
T C Thompson Children's Hospital
Chattanooga Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo Texas, 79106, United States
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, 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
Scott and White Memorial Hospital
Temple Texas, 76508, 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
Inova Fairfax Hospital
Falls Church Virginia, 22042, 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
Carilion Children's
Roanoke Virginia, 24014, 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
Cabell-Huntington Hospital
Huntington West Virginia, 25701, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, 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
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6008, Australia
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Janeway Child Health Centre
Saint John's Newfoundland and Labrador, A1B 3, 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
London Ontario, N6A 5, Canada
Victoria Hospital
London Ontario, N6K 1, 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
San Jorge Children's Hospital
San Juan , 00912, Puerto Rico
Swiss Pediatric Oncology Group - Bern
Bern , 3010, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

395

Study ID:

NCT00379340

Recruitment Status:

Active, not recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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