Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	under 21	NCI	CCG-521

Objectives

I.  Compare relapse-free survival and survival in children with advanced 
Hodgkin's disease treated with alternating courses of MOPP (nitrogen 
mustard/vincristine/prednisone/procarbazine) and ABVD 
(adriamycin/bleomycin/vinblastine/DTIC) for a total of 12 courses of 
chemotherapy vs. 6 courses of ABVD followed by low-dose (2,100 cGy) regional 
radiotherapy.
II.  Compare the immediate and long-term toxicity associated with each of 
these treatment regimens.
III.  Compare the CR rates in the 2 treatment groups after 6 courses of 
chemotherapy.
IV.  Assess whether the 8-drug regimen obviates the need for radiotherapy by 
analyzing the patterns of relapse.
V.  Evaluate patterns and extent of disease at diagnosis and histologic 
subtypes with regard to prognostic significance, specifically pathologic 
subtypes III-1 vs. III-2 and micro vs. macro splenic involvement (more than 4 
vs. 4 or fewer nodules).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients less than 21 years of age at 
diagnosis with pathologically proven Hodgkin's disease of one of the following 
pathologic stages:  III-1AS-macro, III-2A, IIIB, IVA, or IVB.  Patients with 
pathologic Stage III-1A disease with a mediastinal mass greater than one-third 
the diameter of the thorax are also eligible.  The pathologic diagnosis must 
have been established by nodal sampling above and below the diaphragm or by 
positive biopsies of liver, bone, bone marrow, or noncontiguous lung lesions.  
Chest x-ray, thoracic CT, and bone marrow aspiration and biopsy must have been 
performed prior to entry to determine eligibility.  Patients with direct 
contiguous extension of disease from nodal to extra-nodal sites, without 
pathologic proof of Stage III or IV disease as defined above, are ineligible.

Expected Enrollment

200 patients will be entered over about 4 years.

Outline

Randomized study.
Arm I:  4-Drug Combination Chemotherapy Alternating with 4-Drug Combination 
Chemotherapy.  MOPP:  Nitrogen Mustard, NM, NSC-762; Vincristine, VCR, 
NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; 
alternating with ABVD:  Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, 
NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, NSC-45388.
Arm II:  4-Drug Combination Chemotherapy Followed by Radiotherapy.  ABVD; 
followed by regional radiotherapy using Co60 equipment, 4-10 MeV linear 
accelerators, or Betatron (electrons may be used only for boosts).

Hutchinson RJ, Fryer CJ, Davis PC, et al.: MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. J Clin Oncol 16 (3): 897-906, 1998.[PUBMED Abstract]

Maity A, Goldwein JW, Lange B, et al.: Comparison of high-dose and low-dose radiation with and without chemotherapy for children with Hodgkin's disease: an analysis of the experience at the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania. J Clin Oncol 10 (6): 929-35, 1992.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

Raymond Hutchinson, MD, Protocol chair		Ph: 734-936-9814; 800-865-1125