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Spots Global Cancer Trial Database for Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors

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Trial Identification

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

Conditions

Kidney Cancer

Study Description

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

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Daniel M. Green, MD

Affiliation: Roswell Park Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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