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	16 to 65	NCI	EST-4486 CLB-8695, SWOG-8796, INT-0074

Objectives

I.  Randomly compare, in a multi-institution intergroup Phase III setting, the 
CR rate, duration of CR, freedom from progression, and survival among adult 
patients with advanced Hodgkin's disease previously untreated with 
chemotherapy in response to treatment with the MOPP/ABV Hybrid vs. sequential 
MOPP induction and ABVD consolidation.
II.  Prospectively correlate doses of chemotherapy administered with clinical 
outcome.
III.  Analyze and compare the toxicity and the patient tolerance of each of 
these two treatment regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 16-65 years who have 
histologic evidence of advanced Hodgkin's disease, provided that they have not 
received prior chemotherapy, other than a brief exposure to corticosteroids, 
for their disease.  The tissue on which the diagnosis was made must be 
submitted to either the ECOG or the CALGB Pathology Coordinating Office 
immediately following randomization.  Patients must have one of the following 
pathological or clinical stages of disease:  III-2-A, IIIB, IVA, or IVB 
according to the Ann Arbor classification.  Patients with pathologic Stage 
III-1-A are acceptable if they have at least 5 splenic nodules.  Patients with 
clinical Stage III-2-A disease who have not undergone laparotomy must have 
unequivocal clinical documentation of disease below the diaphragm, i.e., 
positive abdominal CT and/or positive lymphangiogram.  Patients with recurrent 
Hodgkin's disease following radiotherapy alone are eligible provided they have 
recurrent disease activity demonstrated by biopsy (strongly recommended) or by 
unequivocal radiologic procedures, and provided they are judged to be not 
salvageable by radiotherapy alone; such patients are eligible regardless of 
initial stage of disease or apparent stage on relapse.  Prior to treatment, 
all patients must undergo CT of the abdomen and/or bipedal lymphangiography 
and must have either a single or a bilateral percutaneous bone marrow biopsy 
or an open bone marrow biopsy.  Marrow biopsy is required even if there is 
documented Stage IV disease at other sites.  A pretreatment liver biopsy is 
strongly recommended in patients with hepatomegaly or significant 
abnormalities in LFTs.  There must be at least one objectively measurable 
disease parameter, including radiographic parameters.  An enlarged liver is 
acceptable as the sole evidence of measurable disease only if there has been a 
positive liver biopsy.  The WBC and platelets must be at least 4,000 and 
100,000, respectively, in the absence of bone marrow involvement or 
hypersplenism, in which cases the required minimal counts are 2,000 and 
75,000.  A serum creatinine of not greater than 2.0 mg/dl is required, and the 
serum bilirubin must not be greater than 5.0 mg/dl, although other 
abnormalities of liver function will not exclude.  Active, uncontrolled 
bacterial, viral, or fungal infections and active nonmalignant duodenal ulcer 
must be corrected or controlled prior to entry.  There must be no severe, 
non-neoplastic pulmonary disease (PFTs less than 50% of predicted values), 
CHF, myocardial infarction within 3 months, severe coronary insufficiency, 
severe diabetes requiring insulin, or intolerance to prednisone.  There may be 
no history of a prior malignancy except for cured carcinoma in situ of the 
cervix or nonmelanomatous skin cancer, and patients must not have AIDS or 
AIDS-related complex.

Expected Enrollment

As of January, 1989, the total accrual goal was 700 patients (633 eligible 
patients), and it was anticipated that accrual would be complete within 6 
months).

Outline

Randomized study.
Arm I:  4-Drug Combination Induction Chemotherapy followed by 4-Drug 
Combination Consolidation Chemotherapy.  MOPP:  Nitrogen Mustard, NM, NSC-762; 
Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, 
NSC-10023; followed by ABVD:  Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, 
NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, NSC-45388.
Arm II:  7-Drug Combination Chemotherapy.  MOPP/ABV Hybrid:  NM; VCR; PCB; 
PRED; ADR; BLEO; VBL.

Glick JH, Young ML, Harrington D, et al.: MOPP/ABV hybrid chemotherapy for advanced Hodgkin's disease significantly improves failure-free and overall survival: the 8-year results of the intergroup trial. J Clin Oncol 16 (1): 19-26, 1998.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

John Glick, MD, Protocol chair		Ph: 215-662-6334 Email: glickjh@mail.med.upenn.edu

Cancer and Leukemia Group B

Richard Schilsky, MD, Protocol chair		Ph: 773-834-3914; 888-824-0200 Email: rschilsk@medicine.bsd.uchicago.edu

Southwest Oncology Group

Thomas Beck, MD, Protocol chair		Ph: 208-381-2711; 800-845-4624