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Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
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.
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.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
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 D.C., 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
Start Date
March 1, 1997
Primary Completion Date
October 1, 2004
Completion Date
June 1, 2008
Last Updated
July 24, 2014
219
ACTUAL participants
bleomycin sulfate
BIOLOGICAL
filgrastim
BIOLOGICAL
cyclophosphamide
DRUG
dexrazoxane hydrochloride
DRUG
doxorubicin hydrochloride
DRUG
etoposide
DRUG
prednisone
DRUG
vincristine sulfate
DRUG
radiation therapy
RADIATION
Lead Sponsor
Children's Oncology Group
Collaborators
NCT05529069
NCT06263491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05139017