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Brief Title: Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
Official Title: National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study
Study ID: NCT00002610
Brief 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. 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.
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
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of South Alabama Medical Center, Mobile, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital of Oakland, Oakland, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, United States
Children's Hospital San Diego, San Diego, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Santa Barbara Cottage Hospital, Santa Barbara, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
Children's Hospital of Denver, Denver, Colorado, United States
Childhood Hematology/Oncology Associates, Denver, Colorado, United States
Presbyterian-St Luke's Medical Center, Denver, Colorado, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Alfred I. Dupont Institute, Wilmington, Delaware, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States
Joe DiMaggio Children's Hospital at Memorial, Hollywood, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
University of Miami-Jackson Memorial Hospital, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Nemours Children's Clinic-Orlando, Orlando, Florida, United States
Sacred Heart Children's Hospital, Pensacola, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
Tampa Children's Hospital, Tampa, Florida, United States
St. Mary's Hospital, West Palm Beach, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite, Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center, Augusta, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Memorial Health University Medical Center, Inc., Savannah, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Mountain States Tumor Institute, Boise, Idaho, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Hope Children's Hospital, Oak Lawn, Illinois, United States
Lutheran General Hospital, Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Raymond Blank Memorial Hospital for Children, Des Moines, Iowa, United States
John Stoddard Cancer Center, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Wesley Medical Center, Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Children's Hospital of New Orleans, New Orleans, Louisiana, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Maine Children's Cancer Program, Scarborough, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Floating Hospital for Children, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Baystate Medical Center, Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
St. John Hospital and Medical Center, Detroit, Michigan, United States
Michigan State University, East Lansing, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Spectrum Health and DeVos Children's Hospital, Grand Rapids, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
St. Mary's/Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Children's Hospitals and Clinics - Minneapolis, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota, Saint Paul, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
St. Louis Children's Hospital, Saint Louis, Missouri, United States
Children's Hospital of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
Atlantic Health System, Summit, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
Brooklyn Hospital Center, Brooklyn, New York, United States
State University of New York Health Science Center at Brooklyn College of Medicine, Brooklyn, New York, United States
Brookdale University Hospital and Medical Center, Brooklyn, New York, United States
Maimonides Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Columbia Presbyterian Hospital, New York, New York, United States
James P. Wilmot Cancer Center, Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Mission Saint Joseph's Health System, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Healthcare, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
East Carolina University School of Medicine, Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Dakota Cancer Institute, Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Children's Hospital of Columbus, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Toledo Children's Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Forum Health-Tod Childrens Hospital, Youngstown, Ohio, United States
Children's Hospital of Oklahoma, Oklahoma City, Oklahoma, United States
CCOP - Oklahoma, Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
Doernbecher Children's Hospital, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sioux Valley Hospital, Sioux Falls, South Dakota, United States
East Tennessee State University Cancer Center at JCMC, Johnson City, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States
Children's Hospital of Austin, Austin, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Health Care System, San Antonio, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Vermont Cancer Center, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Children's Hospital of the King's Daughters, Norfolk, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Carilion Medical Center for Children, Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Group Health Cooperative, Seattle, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Mary Bridge Children's Health Center, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
West Virginia University - Charleston, Charleston, West Virginia, United States
Cabell-Huntington Hospital, Inc, Huntington, West Virginia, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
Bellin Memorial Hospital, Green Bay, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane, Queensland, Australia
Women's and Children's Hospital, North Adelaide, South Australia, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
Children's Hospital, Hamilton, Ontario, Canada
Children's Hospital of Western Ontario, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval, Sainte Foy, Quebec, Canada
Laval University Medical Center, Sainte-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
Starship Children's Hospital, Auckland, , New Zealand
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico
San Jorge Childrens Hospital, Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne, Lausanne, , Switzerland
Name: Daniel M. Green, MD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR