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NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY


Phase 3
N/A
15 Years
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY


OBJECTIVES:

- Increase survival rate of children with favorable histology (FH) Wilms' tumor and other
childhood renal tumors.

- Determine whether loss of heterozygosity for chromosome 16q or 1p in tumor tissue is
associated with a poorer prognosis in children with FH Wilms' tumor.

- Determine whether increased DNA content in tumor cells is associated with a poorer
prognosis in children with FH Wilms' tumor.

- Decrease the acute and long-term morbidity in children with Wilms' tumor by limiting
initial therapy and consistently using the same regimen (protocol NWTS-5/R) for
patients who relapse following initial treatment.

- Improve overall and disease-free survival of patients with renal tumors of unfavorable
histology, including Wilms' tumor with diffuse anaplasia and clear cell sarcoma of the
kidney, using a new treatment regimen that includes etoposide (VP-16) and
cyclophosphamide (CTX).

- Improve overall and disease-free survival in patients with malignant rhabdoid tumor of
the kidney using a new treatment regimen that includes carboplatin, VP-16, and CTX.
(The rhabdoid tumor stratum closed to accrual effective 07/13/2001)

- Provide data regarding loss of heterozygosity for chromosomes 11p15, 16q, and 1p, age
at diagnosis, precursor lesions (perilobar, intralobar, nephroblastomatosis),
bilaterality, and presence of congenital anomalies required for the completion of
protocol A0026 (a case-control study of risk factors for Wilms' tumor).

OUTLINE: This is a multicenter study. Patients are assigned to one of nine strata based on
tumor histology, stage, tumor weight, and age.

- Stratum 1 (stage I favorable histology (FH) Wilms' tumor, under 24 months of age, and
tumor weight less than 550 g): After nephrectomy, patients receive regimen EE-4A
comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18 and
vincristine (VCR) IV weekly on weeks 1-10, 12, 15, and 18.

- Stratum 2 (stage I FH Wilms' tumor and age 24 months and over or tumor weight at least
550 g; stage I focal anaplastic (FA) or diffuse anaplastic (DA) Wilms' tumor): Patients
receive therapy as in stratum 1.

- Stratum 3 (stage II FH Wilms' tumor): Patients receive therapy as in stratum 1.

- Stratum 4 (stage III FH Wilms' tumor; stage II or III FA Wilms' tumor): After
nephrectomy, patients receive regimen DD-4A comprising DACT IV weekly on weeks 0, 6,
12, 18, and 24; doxorubicin IV weekly on weeks 3, 9, 15, and 21; and VCR IV weekly on
weeks 1-10, 12, 15, 18, 21, and 24. Patients also undergo abdominal radiotherapy.

- Stratum 5 (stage IV FH or FA Wilms' tumor): Patients receive chemotherapy as in stratum
4, abdominal radiotherapy, and whole lung radiotherapy (at the discretion of the
investigator).

- Stratum 6 (stage V FH, FA, or DA Wilms' tumor ): After bilateral biopsy, patients with
FH receive chemotherapy as in stratum 1 or 4. Patients with FA or DA receive
chemotherapy as in stratum 7.

- Stratum 7 (stages I-IV clear cell sarcoma): After nephrectomy, patients receive VCR IV
weekly on weeks 1, 2, 4-8, 10-13, 18, and 24; cyclophosphamide (CTX) IV over 1 hour on
days 1-3 of weeks 6, 12, 18, and 24 and on days 1-5 of weeks 3, 9, 15, and 21;
doxorubicin IV (beginning after CTX infusion) weekly on weeks 0, 6, 12, 18, and 24; and
etoposide (VP-16) IV over 1 hour (beginning after CTX infusion) on days 1-5 of weeks 3,
9, 15, and 21. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24
hours after completion of chemotherapy and continuing until blood counts recover.
Patients also undergo abdominal radiotherapy and whole lung radiotherapy (if pulmonary
metastases are present).

- Stratum 8 (stages II-IV DA Wilms' tumor): Patients receive treatment as in stratum 7.

- Stratum 9 (stages I-IV rhabdoid tumor): After nephrectomy, patients receive carboplatin
IV on days 1-2 and VP-16 IV over 1 hour (beginning after carboplatin infusion) on days
1-3 of weeks 0, 3, 9, 12, 18, and 21 and CTX IV over 1 hour on days 1-5 of weeks 6, 15,
and 24. G-CSF is administered as in stratum 7. Patients also undergo radiotherapy. (The
rhabdoid tumor stratum closed to accrual effective 07/13/2001.) After completion of
chemotherapy, patients undergo second-look laparotomy and partial nephrectomy or wedge
excision (if feasible). After second-look surgery, patients without persistent or
residual disease resume chemotherapy.

Patients are followed every 3 months for 5 years, every 6 months for 2 years, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 207 patients will be accrued for the treatment portion of this
study. (The rhabdoid tumor stratum closed to accrual effective 07/13/2001.)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage I-V kidney cancer of one of the following histologies:

- Wilms' tumor, favorable histology

- Wilms' tumor, focal or diffuse anaplastic

- Clear cell sarcoma

- Rhabdoid tumor

- (The rhabdoid tumor stratum closed to accrual effective 07/13/2001)

- Prior nephrectomy or biopsy required

- Prior bilateral biopsy (preferably open) with bilateral staging and pathologic
evaluation required for bilateral tumor

- Must begin study therapy within 5 days after nephrectomy (unless medically
contraindicated)

PATIENT CHARACTERISTICS:

Age:

- Under 16

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel M. Green, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000063901

NCT ID:

NCT00002611

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage I Wilms tumor
  • stage II Wilms tumor
  • stage III Wilms tumor
  • stage IV Wilms tumor
  • stage V Wilms tumor
  • clear cell sarcoma of the kidney
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Wilms Tumor

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Rhode Island HospitalProvidence, Rhode Island  02903
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Bronson Methodist HospitalKalamazoo, Michigan  49007
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Lombardi Cancer CenterWashington, District of Columbia  20007
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Marshfield ClinicMarshfield, Wisconsin  54449
Loma Linda University Medical CenterLoma Linda, California  92354
David Grant Medical CenterTravis Air Force Base, California  94535
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Deaconess Medical CenterSpokane, Washington  99210-0248
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cedars-Sinai Medical CenterLos Angeles, California  90048
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Eastern Maine Medical CenterBangor, Maine  04401
Baystate Medical CenterSpringfield, Massachusetts  01199
Michigan State UniversityEast Lansing, Michigan  48824
CCOP - OklahomaTulsa, Oklahoma  74136
William Beaumont HospitalRoyal Oak, Michigan  48073
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
University of South Alabama Medical CenterMobile, Alabama  36604
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Children's Hospital San DiegoSan Diego, California  92123-4282
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Joe DiMaggio Children's Hospital at MemorialHollywood, Florida  33021
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Sacred Heart Children's HospitalPensacola, Florida  32504
All Children's HospitalSt. Petersburg, Florida  33701
Tampa Children's HospitalTampa, Florida  33677-4227
St. Mary's HospitalWest Palm Beach, Florida  33407
Children's Healthcare of Atlanta - Scottish RiteAtlanta, Georgia  30342
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Floating Hospital for ChildrenBoston, Massachusetts  02111
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
St. John Hospital and Medical CenterDetroit, Michigan  48236
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
James P. Wilmot Cancer CenterRochester, New York  14642
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
East Tennessee State University Cancer Center at JCMCJohnson City, Tennessee  37604
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Scott and White Memorial HospitalTemple, Texas  76508
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Carilion Medical Center for ChildrenRoanoke, Virginia  24029
West Virginia University - CharlestonCharleston, West Virginia  25302
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lutheran General HospitalPark Ridge, Illinois  60068
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mountain States Tumor InstituteBoise, Idaho  83712
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Jonathan Jaques Children's Cancer CenterLong Beach, California  90801-1428
Children's Hospital Central CaliforniaMadera, California  93638-8762
Children's Hospital of OaklandOakland, California  94609-1809
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Santa Barbara Cottage HospitalSanta Barbara, California  93102
Childhood Hematology/Oncology AssociatesDenver, Colorado  80218
Presbyterian-St Luke's Medical CenterDenver, Colorado  80218
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Alfred I. Dupont InstituteWilmington, Delaware  19899
University of Miami-Jackson Memorial HospitalMiami, Florida  33136
Medical Center of Central GeorgiaMacon, Georgia  31201
Memorial Health University Medical Center, Inc.Savannah, Georgia  31403-3089
University of Illinois at ChicagoChicago, Illinois  60612
Hope Children's HospitalOak Lawn, Illinois  60453
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
John Stoddard Cancer CenterDes Moines, Iowa  50309
Raymond Blank Memorial Hospital for ChildrenDes Moines, Iowa  50308
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Ochsner ClinicNew Orleans, Louisiana  70121
Mott Children's HospitalAnn Arbor, Michigan  48109-0914
Spectrum Health and DeVos Children's HospitalGrand Rapids, Michigan  49503
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
St. Mary's/Duluth Clinic Cancer CenterDuluth, Minnesota  55805-1983
Children's Hospitals and Clinics - MinneapolisMinneapolis, Minnesota  55404
Children's Hospitals and Clinics of MinnesotaSaint Paul, Minnesota  55102
St. Louis Children's HospitalSaint Louis, Missouri  63110
Children's Hospital of OmahaOmaha, Nebraska  68114
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Atlantic Health SystemSummit, New Jersey  07901
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
Brooklyn Hospital CenterBrooklyn, New York  11201
State University of New York Health Science Center at Brooklyn College of MedicineBrooklyn, New York  11203
Maimonides Medical CenterBrooklyn, New York  11219
Columbia Presbyterian HospitalNew York, New York  10032
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Toledo Children's HospitalToledo, Ohio  43601
Forum Health-Tod Childrens HospitalYoungstown, Ohio  44501
Children's Hospital of OklahomaOklahoma City, Oklahoma  73104
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
Sioux Valley HospitalSioux Falls, South Dakota  57117
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Children's Hospital of AustinAustin, Texas  78701
Covenant Children's HospitalLubbock, Texas  79410
Methodist Health Care SystemSan Antonio, Texas  78229-3902
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Group Health CooperativeSeattle, Washington  98112
Mary Bridge Children's Health CenterTacoma, Washington  98415-0299
Cabell-Huntington Hospital, IncHuntington, West Virginia  25701
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001