Clinical Trial: Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Pediatric Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage II childhood Hodgkin's disease
stage III childhood Hodgkin's disease
stage IV childhood Hodgkin's disease
cardiac toxicity
stage I childhood Hodgkin's disease
 Drug: bleomycin
 Drug: cyclophosphamide
 Drug: dexrazoxane
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: prednisone
 Drug: vincristine
Phase III

MedlinePlus related topics:  Hodgkin's Disease;   Poisoning

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase III Randomized Study of Combination Chemotherapy With or Without Dexrazoxane in Children With Advanced Stage Hodgkin's Disease

Further Study Details: 

Study start: March 1997

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.

PROTOCOL 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

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--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

--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

Location Information


Alabama
      MBCCOP - University of South Alabama, Mobile,  Alabama,  36688,  United States

      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

California
      Lucile Packard Children's Hospital at Stanford, Palo Alto,  California,  94304,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      CCOP - Florida Pediatric, Tampa,  Florida,  33682-7757,  United States

      Miami Children's Hospital, Miami,  Florida,  33155,  United States

      Shands Hospital and Clinics, University of Florida, Gainesville,  Florida,  32610-100277,  United States

      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

Illinois
      Children's Memorial Hospital, Chicago, Chicago,  Illinois,  60614,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States

      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States

      Ochsner Clinic, New Orleans,  Louisiana,  70121,  United States

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231,  United States

      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Boston Floating Hospital Infants and Children, Boston,  Massachusetts,  02111,  United States

      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      Cardinal Glennon Children's Hospital, Saint Louis,  Missouri,  63104,  United States

      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States

      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States

New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States

      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States

North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States

      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      East Carolina University School of Medicine, Greenville,  North Carolina,  27858-4354,  United States

      Memorial Mission Hospital, Asheville,  North Carolina,  28801,  United States

      Presbyterian Healthcare, Charlotte,  North Carolina,  28233-3549,  United States

Oklahoma
      Oklahoma Memorial Hospital, Oklahoma City,  Oklahoma,  73126-0307,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

Pennsylvania
      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States

South Carolina
      Children's Hospital of Greenville Hospital System, Greenville,  South Carolina,  29605,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Tennessee
      Saint Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

      MBCCOP - South Texas Pediatric, San Antonio,  Texas,  78284-7810,  United States

      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States

      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

      Naval Medical Center, Portsmouth, Portsmouth,  Virginia,  23708-2197,  United States

Wisconsin
      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada

      McMaster Division, Hamilton,  Ontario,  L8N 3Z5,  Canada

Canada, Quebec
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada

      Montreal Children's Hospital, Montreal,  Quebec,  H3H 1P3,  Canada

Switzerland
      Swiss Pediatric Oncology Group Bern, Bern,  CH 3010,  Switzerland

Study chairs or principal investigators

Cindy Schwartz,  Study Chair,  Pediatric Oncology Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065359; POG-9425
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005578
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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