AzTrials
AzTrials

Kidney CancerPhase 3NCT00002610

Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors

A Phase 3 study testing dactinomycin, filgrastim and carboplatin in people with Kidney Cancer, run by Children's Oncology Group at 235 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Kidney Cancer
What is being tested?
dactinomycin, filgrastim and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
235 sitesin 7 countries
Study dates
Jan 1996to Feb 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of Wilms' tumor
  • Eligible subtypes:
  • Favorable histologies
  • Anaplastic histologies
  • Clear cell sarcoma of the kidney
  • Rhabdoid tumor of the kidney
  • Relapsed disease after entry on protocol NWTS-5 (NWTS-Q9401)

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at original diagnosis

Performance status:

  • Not specified

Life expectancy:

  • At least 4 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT or SGPT less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or GFR at least 70 mL/min

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction greater than 50% by echocardiogram or MUGA scan

Other:

  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 2 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior therapy for relapsed Wilms' tumor
  • Recovered from the toxic effects of any other prior therapy

Trial locations and contacts

235 sites in 7 countries.

235 sites in 7 countries

United States206 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • Mott Children's Hospital

    Ann Arbor, Michigan, 48109-0914

  • Mission Saint Joseph's Health System

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Children's Healthcare of Atlanta - Scottish Rite

    Atlanta, Georgia, 30342

  • Medical College of Georgia Comprehensive Cancer Center

    Augusta, Georgia, 30912-4000

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201-1595

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • State University of New York Health Science Center at Brooklyn College of Medicine

    Brooklyn, New York, 11203

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Charleston

    Charleston, West Virginia, 25302

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60601

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Children's Hospital Medical Center - Cincinnati

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Children's Hospital of Columbus

    Columbus, Ohio, 43205-2696

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404

  • Children's Hospital of Denver

    Denver, Colorado, 80218-1088

  • Childhood Hematology/Oncology Associates

    Denver, Colorado, 80218

  • Presbyterian-St Luke's Medical Center

    Denver, Colorado, 80218

  • Raymond Blank Memorial Hospital for Children

    Des Moines, Iowa, 50308

  • John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's/Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805-1983

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Michigan State University

    East Lansing, Michigan, 48824

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103-4940

  • University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Spectrum Health and DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Cabell-Huntington Hospital, Inc

    Huntington, West Virginia, 25701

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at JCMC

    Johnson City, Tennessee, 37604

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109-2306

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0284

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center

    Long Beach, California, 90801-1428

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-3830

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-0001

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5772

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • University of Miami-Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155-4069

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of South Alabama Medical Center

    Mobile, Alabama, 36604

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021-4885

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia Presbyterian Hospital

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital of Oakland

    Oakland, California, 94609-1809

  • Children's Hospital of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32803

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Lutheran General Hospital

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Doernbecher Children's Hospital

    Portland, Oregon, 97201-3098

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02818

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Medical Center for Children

    Roanoke, Virginia, 24013

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Children's Hospitals and Clinics of Minnesota

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Health Care System

    San Antonio, Texas, 78229-3902

  • 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 - San Francisco Geary Campus

    San Francisco, California, 94115

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Memorial Health University Medical Center, Inc.

    Savannah, Georgia, 31403-3089

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-1080

  • Sioux Valley Hospital

    Sioux Falls, South Dakota, 57117

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9658

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Atlantic Health System

    Summit, New Jersey, 07901

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Mary Bridge Children's Health Center

    Tacoma, Washington, 98415-0299

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Tampa Children's Hospital

    Tampa, Florida, 33677-4227

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • Toledo Children's Hospital

    Toledo, Ohio, 43601

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. Dupont Institute

    Wilmington, Delaware, 19899

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Forum Health-Tod Childrens Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada16 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • Children's Hospital of Western Ontario

    London, Ontario, N6C 2V5

  • McGill University Health Center - Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Laval University Medical Center

    Sainte-Foy, Quebec, G1V 4G2

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, CH 1011

Other trials in Switzerland

Puerto Rico2 sites

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9700 RB

Other trials in Netherlands

New Zealand1 site

  • Starship Children's Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.

Read the detailed description

OBJECTIVES:

  • Determine the 2-year second-event-free survival after vincristine (VCR) and dactinomycin (DACT) with or without doxorubicin (DOX), depending on the site of relapse and presence of microscopic residual disease, in children with relapsed Wilm's tumor previously treated with nephrectomy alone as initial therapy.
  • Determine whether the 2-year second-event-free survival after intensive doxorubicin, etoposide (VP-16), cyclophosphamide (CTX), and carboplatin (CBDCA) plus radiotherapy to residual disease is at least 40% higher in patients with relapsed Wilm's tumor previously treated with Regimen EE-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells.
  • Determine whether the 4-year post-relapse survival after intensive VP-16, CTX, and CBDCA is at least 40% higher in patients with relapsed Wilm's tumor previously treated with Regimen DD-4A as initial therapy and without loss of heterozygosity for chromosomes 16q and 1p and increased DNA content in tumor cells than for similarly treated patients with loss of heterozygosity for chromosome 16q or 1p or increased DNA content in tumor cells.
  • Determine whether the rates of complete and partial response exceed 20% in patients with relapsed clear cell sarcoma of the kidney or diffuse anaplastic Wilms' tumor treated with CBDCA combined with VP-16.

OUTLINE: This is a multicenter study.

Patients are assigned to a treatment group based on initial therapy and histology. Patients under age 2 at diagnosis who were previously treated with nephrectomy as initial therapy for stage I favorable histology Wilms' tumor weighing less than 550 grams are assigned to group A. Patients who received Regimen EE-4A as initial therapy for Wilms' tumor are assigned to group B. Patients who received Regimen DD-4A as initial therapy for Wilms' tumor are assigned to group C. Patients with clear cell sarcoma of the kidney or diffuse anaplastic Wilms' tumor are assigned to group D.

Group A

  • Treatment is determined by site of relapse and the presence of microscopic or gross residual disease after attempted resection of relapsed disease. Children with suspected intra-abdominal recurrence undergo exploratory surgery to determine the site of recurrence and to obtain tissue for microscopic examination. Patients with stage I disease after recurrence are treated with regimen EE-4A. Patients with stage II or III disease are treated with regimen DD-4A.
  • Regimen EE-4A: Patients receive dactinomycin (DACT) IV on weeks 0, 3, 6, 9, 12, 15, and 18 and vincristine (VCR) IV on weeks 1-10, 12, 15, and 18 in the absence of disease progression.
  • Regimen DD-4A: Patients receive DACT IV on weeks 0, 6, 12, 18, and 24; VCR IV weekly on weeks 1-10, 12, 15, 18, 21, and 24; doxorubicin (DOX) IV on weeks 3, 9, 15, and 21; and abdominal radiotherapy in the absence of disease progression.

Group B

  • Patients undergo resection. After resection, patients receive regimen I comprising DOX IV on weeks 0, 6, 12, 18, and 24; VCR IV on weeks 1, 2, 4, 5-8, 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; and etoposide (VP-16) IV over 1 hour (after CTX infusion) on days 1-5 of weeks 3, 9, 15, and 21 in the absence of disease progression. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Patients undergo radiotherapy to site of recurrence beginning within 1 week after initiation of chemotherapy.

Group C

  • Induction: Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3; VP-16 IV over 1 hour (after CTX infusion) on days 1-5 of weeks of 0 and 3 and on days 1-3 of weeks 6 and 9; and carboplatin (CBDCA) IV over 6 hours on days 1 and 2 of weeks 6 and 9 in the absence of disease progression. G-CSF is administered SC beginning 24 hours after completion of CTX/VP-16 or CBDCA/VP-16 and continuing until blood counts recover.
  • Surgery: Patients with detectable disease undergo resection on week 13. If complete resection is not achieved or if it is deemed impossible, resection must be attempted no later than 3 weeks after consolidation radiotherapy.
  • Consolidation: Beginning within 9 days of surgery, patients receive CTX IV over 1 hour on days 1-5 of week 1; VP-16 IV over 1 hour (after CTX infusion) on days 1-5 of week 1 and on days 1-3 of week 4; CBDCA IV over 6 hours on days 1 and 2 of week 4; G-CSF as in induction; and radiotherapy in the absence of disease progression. Patients with complete or partial response after resection and/or radiotherapy proceed to maintenance therapy.
  • Maintenance: Patients receive CTX IV over 1 hour on days 1-5 of weeks 0 and 3; VP-16 IV over 1 hour on days 1-5 of weeks 0 and 3 and on days 1-3 of weeks 6 and 9; CBDCA IV over 6 hours on days 1 and 2 of weeks 6 and 9; and G-CSF as in induction. Treatment continues every 12 weeks for 6 courses in the absence of disease progression.

Group D

  • Patients receive CBDCA IV over 6 hours on days 1 and 2 and VP-16 IV over 1 hour (after CBDCA infusion) on days 1-3 of weeks 0 and 3. Treatment continues weekly for 6 courses in the absence of disease progression.

Patients are followed every 3 months for 15 months, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: Not specified

Conditions
Kidney Cancer
Keywords
recurrent Wilms tumor and other childhood kidney tumors, clear cell sarcoma of the kidney, rhabdoid tumor of the kidney
Medical subject headings
Kidney Neoplasms, Wilms Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002610
Study groupRoleWhat they receive
STRATUM AExperimentalTreatment of children in Stratum A will be determined by the site of relapse and the presence of microscopic or gross residual disease after attempted surgical excision of the relapse.
Receives: Biological: dactinomycin; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate; Procedure: conventional surgery; Radiation: radiation therapy
Stratum BExperimentalAll children who received combination chemotherapy with Regimen EE - 4A as their initial therapy for Wilms tumor will receive Regimen I and radiation therapy to the site of recurrence. All patients will receive prophylactic trimethoprim /sulfamethoxazole
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: vincristine sulfate; Procedure: conventional surgery; Radiation: radiation therapy
STRATUM CExperimentalAll children who received combination chemotherapy with Regimen DD - 4A as their initial therapy for Wilms tumor will be treated with the following chemotherapy. All patients will receive prophylactic trimethoprim/sulfamethoxazole
Receives: Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: etoposide; Procedure: conventional surgery; Radiation: radiation therapy
STRATUM DExperimentalSix week cycles of chemotherapy will be given to all patients who do not have progressive disease at the time of each week 0 re-evaluation.
Receives: Drug: carboplatin; Drug: etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event free survival

    To determine the two-year second event-free survival percentage for children who relapse following initial therapy with nephrectomy only following treatment with vincristine and dactinomycin, with or without doxorubicin, depending upon the site of relapse and presence or absence of microscopic residual disease.

    Measured: 2 years

Secondary outcomes (3)

  1. Event Free Survival

    To determine if the two-year second event-free survival percentage for children who relapse following initial treatment with Regimen EE-4A who do not have loss of heterozygosity of markers for chromosome 16q, 1p or increased DNA content in tumor cells is not less than 40% higher than that of similar patients who have loss of heterozygosity for chromosome 16q, 1p or increased DNA content following treatment with intensive chemotherapy using doxorubicin, etoposide, cyclophosphamide and carboplatin, and radiation therapy to sites of microscopic or gross residual disease.

    Measured: 2 years

  2. Post-relapse survival

    To determine if the four-year post-relapse survival percentage for children who relapse following initial treatment with Regimen DD - 4A who do not have loss of heterozygosity of markers for chromosome 16q, 1p or increased DNA content in tumor cells is not less than 40% higher than that of similar patients who have loss of heterozygosity for chromosome 16q, 1p or increased DNA content following treatment with intensive chemotherapy using etoposide, cyclophosphamide and carboplatin.

    Measured: 4 years

  3. Response rate

    To determine if the response rate (CR + PR) of clear cell sarcoma of the kidney and diffuse anaplastic Wilms tumor to the combination of carboplatin and etoposide each exceed 20%.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 1996
  3. Primary completionJun 2002
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002610
Sponsor's protocol ID
9444
Other IDs
COG-Q9402, NWTS-Q9402, CCG-4942, POG-9444, INT-0152, NWTS-5/R, CDR0000063900
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
25 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kalapurakal JA, Perlman EJ, Seibel NL, Ritchey M, Dome JS, Grundy PE. Outcomes of patients with revised stage I clear cell sarcoma of kidney treated in National Wilms Tumor Studies 1-5. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):428-31. doi: 10.1016/j.ijrobp.2012.04.023. Epub 2012 Jun 1.

    PubMed 22658515

  • Green DM, Cotton CA, Malogolowkin M, Breslow NE, Perlman E, Miser J, Ritchey ML, Thomas PR, Grundy PE, D'Angio GJ, Beckwith JB, Shamberger RC, Haase GM, Donaldson M, Weetman R, Coppes MJ, Shearer P, Coccia P, Kletzel M, Macklis R, Tomlinson G, Huff V, Newbury R, Weeks D. Treatment of Wilms tumor relapsing after initial treatment with vincristine and actinomycin D: a report from the National Wilms Tumor Study Group. Pediatr Blood Cancer. 2007 May;48(5):493-9. doi: 10.1002/pbc.20822.

    PubMed 16547940

  • Ehrlich PF, Anderson JR, Ritchey ML, Dome JS, Green DM, Grundy PE, Perlman EJ, Kalapurakal JA, Breslow NE, Shamberger RC. Clinicopathologic findings predictive of relapse in children with stage III favorable-histology Wilms tumor. J Clin Oncol. 2013 Mar 20;31(9):1196-201. doi: 10.1200/JCO.2011.41.1165. Epub 2013 Feb 4.

    PubMed 23382471

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dactinomycin, filgrastim and carboplatin in people with Kidney Cancer, run by Children's Oncology Group at 235 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002610, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in