Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease
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Trial Identification
Brief Title: Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease
Official Title: Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
Study ID: NCT00005578
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.
Detailed Description: OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given. Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter. PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
MBCCOP - University of South Alabama, Mobile, Alabama, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
CCOP - Florida Pediatric, Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Memorial Mission Hospital, Asheville, 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 of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital, Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program, Portland, Oregon, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
MBCCOP - South Texas Pediatric, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
McMaster Division, Hamilton, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Contact Details
Name: Cindy Schwartz, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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