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

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Toxicity; Lymphoma

Intervention: bleomycin sulfate (Biological); filgrastim (Biological); cyclophosphamide (Drug); dexrazoxane hydrochloride (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)

Phase: Phase 3

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Cindy Schwartz, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Diffusing capacity of the lungs for carbon monoxide (DLCO)

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: N/A. Maximum age: 21 Years. Gender(s): Both.

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

Locations and Contacts

Swiss Pediatric Oncology Group Bern, Bern CH 3010, Switzerland

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hackensack University Medical Center, Hackensack, New Jersey 07601, 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

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

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

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

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

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

Presbyterian Healthcare, Charlotte, North Carolina 28233-3549, 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

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

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

McMaster Division, Hamilton, Ontario L8N 3Z5, Canada

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Additional Information

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

Related publications:

Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500.

Schwartz CL, Tebbi CK, Constine LS: Response based therapy for pediatric Hodgkin's disease (HD): Pediatric Oncology Group (POG) protocols 9425/9426. [Abstract] Med Pediatr Oncol 37 (3): A-P219, 263, 2001.

Starting date: March 1997
Last updated: July 23, 2014

Page last updated: August 23, 2015

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