Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Cindy Schwartz, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000065359
NCT00005578
March 1997
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
University of California Davis Medical Center | Sacramento, California 95817 |
Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Florida Pediatric | Tampa, Florida 33682-7757 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Mount Sinai School of Medicine | New York, New York 10029 |
Memorial Mission Hospital | Asheville, North Carolina 28801 |
Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
Oklahoma Memorial Hospital | Oklahoma City, Oklahoma 73126-0307 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
Ochsner Clinic | New Orleans, Louisiana 70121 |
Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |
MBCCOP - South Texas Pediatric | San Antonio, Texas 78284-7810 |