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Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study


Phase 3
N/A
21 Years
Not Enrolling
Both
Cardiac Toxicity, Lymphoma

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages:
Stages IIB, IIIB or IV

PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2
times upper normal limit Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Less than one week of steroids for management of
airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the
mediastinum Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Cindy Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065359

NCT ID:

NCT00005578

Start Date:

March 1997

Completion Date:

Related Keywords:

  • Cardiac Toxicity
  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • cardiac toxicity
  • Hodgkin Disease
  • Lymphoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Children's Hospital of MichiganDetroit, Michigan  48201
Mount Sinai School of MedicineNew York, New York  10029
Memorial Mission HospitalAsheville, North Carolina  28801
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
MBCCOP - University of South AlabamaMobile, Alabama  36688
CCOP - Columbia River ProgramPortland, Oregon  97213
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Hackensack University Medical CenterHackensack, New Jersey  07601
Miami Children's HospitalMiami, Florida  33155-4069
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Ochsner ClinicNew Orleans, Louisiana  70121
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810