NCT00005578

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiac Toxicity
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate
BIOLOGICAL	filgrastim
DRUG	cyclophosphamide
DRUG	dexrazoxane hydrochloride
DRUG	doxorubicin hydrochloride
DRUG	etoposide
DRUG	prednisone
DRUG	vincristine sulfate
RADIATION	radiation therapy

Timeline

• Start date: 1997-03-01
• Primary completion: 2004-10-01
• Completion: 2008-06-01
• First posted: 2004-05-26
• Last updated: 2014-07-24

Locations

63 sites across 3 countries: United States, Canada, Switzerland