Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Completed	21 and under	NCI	COG-9425 NCT00005578, POG-9425

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.

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 

Expected Enrollment

A total of 277 patients will be accrued for this study within 3 years.

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.

Schwartz CL, Constine LS, Villaluna D, et al.: A risk-adapted, response-based approach using ABVE-PC for children and adolescents with intermediate- and high-risk Hodgkin lymphoma: the results of P9425. Blood 114 (10): 2051-9, 2009.[PUBMED Abstract]

Constine LS, Marcus R, Chauvenet A, et al.: Patterns of failure after response-based, dose-dense therapy for intermediate/high risk pediatric Hodgkin's disease (POG 9425). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-37, S21, 2005.

Schwartz CL, Constine LS, London W, et al.: POG 9425: response-based, intensively timed therapy for intermediate/high stage (IS/HS) pediatric Hodgkin's disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1555, 2002.

Tebbi CK, London WB, Friedman D, et al.: Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol 25 (5): 493-500, 2007.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Cindy Schwartz, MD, Protocol chair(Contact information may not be current)		Ph: 410-955-8964

Registry Information
Official Title		Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
Trial Start Date		1997-03-15
Registered in ClinicalTrials.gov		NCT00005578
Date Submitted to PDQ		1997-03-15
Information Last Verified		2009-07-10
NCI Grant/Contract Number		U10-CA30969

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