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Phase 3
15 Years
Not Enrolling
Kidney Cancer

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Trial Information



- 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

- 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


- 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



- Under 16

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Not pregnant

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel M. Green, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:




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



Baylor College of Medicine Houston, Texas  77030
Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Ireland Cancer Center Cleveland, Ohio  44106-5065
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Rhode Island Hospital Providence, Rhode Island  02903
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Vermont Cancer Center Burlington, Vermont  05401-3498
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
State University of New York - Upstate Medical University Syracuse, New York  13210
St. Vincent Hospital and Health Care Center Indianapolis, Indiana  46260
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Avera Cancer Institute Sioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Lombardi Cancer Center Washington, District of Columbia  20007
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Marshfield Clinic Marshfield, Wisconsin  54449
Loma Linda University Medical Center Loma Linda, California  92354
David Grant Medical Center Travis Air Force Base, California  94535
Baptist Hospital of Miami Miami, Florida  33176-2197
Tulane University School of Medicine New Orleans, Louisiana  70112
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
University of Texas Medical Branch Galveston, Texas  77555-1329
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Deaconess Medical Center Spokane, Washington  99210-0248
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cedars-Sinai Medical Center Los Angeles, California  90048
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
Medical College of Georgia Comprehensive Cancer Center Augusta, Georgia  30912-4000
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Eastern Maine Medical Center Bangor, Maine  04401
Baystate Medical Center Springfield, Massachusetts  01199
Michigan State University East Lansing, Michigan  48824
CCOP - Oklahoma Tulsa, Oklahoma  74136
William Beaumont Hospital Royal Oak, Michigan  48073
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's Hospital of Denver Denver, Colorado  80218
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Columbus Columbus, Ohio  43205-2696
Doernbecher Children's Hospital Portland, Oregon  97201-3098
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
University of South Alabama Medical Center Mobile, Alabama  36604
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego San Diego, California  92120
Children's Hospital San Diego San Diego, California  92123-4282
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California  95051-5386
Broward General Medical Center Fort Lauderdale, Florida  33316
Children's Hospital of Southwest Florida Fort Myers, Florida  33908
Joe DiMaggio Children's Hospital at Memorial Hollywood, Florida  33021
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
Florida Hospital Cancer Institute Orlando, Florida  32804
Nemours Children's Clinic-Orlando Orlando, Florida  32806
Sacred Heart Children's Hospital Pensacola, Florida  32504
All Children's Hospital St. Petersburg, Florida  33701
Tampa Children's Hospital Tampa, Florida  33677-4227
St. Mary's Hospital West Palm Beach, Florida  33407
Children's Healthcare of Atlanta - Scottish Rite Atlanta, Georgia  30342
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Wesley Medical Center Wichita, Kansas  67214
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Maine Children's Cancer Program Scarborough, Maine  04074-9308
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
Floating Hospital for Children Boston, Massachusetts  02111
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
St. John Hospital and Medical Center Detroit, Michigan  48236
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Schneider Children's Hospital New Hyde Park, New York  11042
James P. Wilmot Cancer Center Rochester, New York  14642
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health Center Portland, Oregon  97227
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
East Tennessee State University Cancer Center at JCMC Johnson City, Tennessee  37604
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Scott and White Memorial Hospital Temple, Texas  76508
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Carilion Medical Center for Children Roanoke, Virginia  24029
West Virginia University - Charleston Charleston, West Virginia  25302
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Lutheran General Hospital Park Ridge, Illinois  60068
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Mountain States Tumor Institute Boise, Idaho  83712
Albert Einstein Clinical Cancer Center Bronx, New York  10461
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Jonathan Jaques Children's Cancer Center Long Beach, California  90801-1428
Children's Hospital Central California Madera, California  93638-8762
Children's Hospital of Oakland Oakland, California  94609-1809
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Santa Barbara Cottage Hospital Santa Barbara, California  93102
Childhood Hematology/Oncology Associates Denver, Colorado  80218
Presbyterian-St Luke's Medical Center Denver, Colorado  80218
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Alfred I. Dupont Institute Wilmington, Delaware  19899
University of Miami-Jackson Memorial Hospital Miami, Florida  33136
Medical Center of Central Georgia Macon, Georgia  31201
Memorial Health University Medical Center, Inc. Savannah, Georgia  31403-3089
University of Illinois at Chicago Chicago, Illinois  60612
Hope Children's Hospital Oak Lawn, Illinois  60453
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
John Stoddard Cancer Center Des Moines, Iowa  50309
Raymond Blank Memorial Hospital for Children Des Moines, Iowa  50308
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Ochsner Clinic New Orleans, Louisiana  70121
Mott Children's Hospital Ann Arbor, Michigan  48109-0914
Spectrum Health and DeVos Children's Hospital Grand Rapids, Michigan  49503
CCOP - Beaumont Royal Oak, Michigan  48073-6769
St. Mary's/Duluth Clinic Cancer Center Duluth, Minnesota  55805-1983
Children's Hospitals and Clinics - Minneapolis Minneapolis, Minnesota  55404
Children's Hospitals and Clinics of Minnesota Saint Paul, Minnesota  55102
St. Louis Children's Hospital Saint Louis, Missouri  63110
Children's Hospital of Omaha Omaha, Nebraska  68114
Sunrise Hospital and Medical Center Las Vegas, Nevada  89109-2306
Atlantic Health System Summit, New Jersey  07901
Brookdale University Hospital and Medical Center Brooklyn, New York  11212
Brooklyn Hospital Center Brooklyn, New York  11201
State University of New York Health Science Center at Brooklyn College of Medicine Brooklyn, New York  11203
Maimonides Medical Center Brooklyn, New York  11219
Columbia Presbyterian Hospital New York, New York  10032
Mission Saint Joseph's Health System Asheville, North Carolina  28801
Dakota Cancer Institute Fargo, North Dakota  58103-4940
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Children's Medical Center - Dayton Dayton, Ohio  45404
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Toledo Children's Hospital Toledo, Ohio  43601
Forum Health-Tod Childrens Hospital Youngstown, Ohio  44501
Children's Hospital of Oklahoma Oklahoma City, Oklahoma  73104
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
Sioux Valley Hospital Sioux Falls, South Dakota  57117
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Texas Tech University Health Sciences Center School of Medicine Amarillo, Texas  79106
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Methodist Health Care System San Antonio, Texas  78229-3902
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Group Health Cooperative Seattle, Washington  98112
Mary Bridge Children's Health Center Tacoma, Washington  98415-0299
Cabell-Huntington Hospital, Inc Huntington, West Virginia  25701
Bellin Memorial Hospital Green Bay, Wisconsin  54301
Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001