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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	16 and over	NCI	CLB-8251 CALGB-8251

Objectives

I.  Compare in a prospective randomized trial the therapeutic efficacy and 
toxicity of three treatment regimens for patients with Stage III2A, IIIB, and 
IV Hodgkin's disease:  MOPP (nitrogen 
mustard/vincristine/procarbazine/prednisone) as initial therapy, with ABVD 
(adriamycin/bleomycin/vinblastine/DTIC) for failures and relapses vs. ABVD as 
initial therapy, with MOPP for failures and relapses vs. alternating courses 
of MOPP and ABVD as initial therapy.
II.  Compare fertility, risk of a second malignancy, cardiotoxicity, and 
pulmonary toxicity in groups of patients treated with either ABVD or MOPP.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 16 years and over with 
a histologically documented diagnosis of Hodgkin's disease, Stage III2A, IIIB, 
or IV (modified Ann Arbor) who have at least one tumor mass measurable in 2 
perpendicular diameters by either physical examination, x-ray or radioisotopic 
scan.  Liver enlargement without biopsy-documentation of Hodgkin's disease, 
splenic enlargement as the only measurable disease, bone abnormalities on scan 
but not on x-ray, and cytologically negative pleural or peritoneal effusions 
are not acceptable measurable disease parameters.  Patients may have failed 
adequate prior mantle or inverted Y radiotherapy (at least 3 months must have 
elapsed following therapy) or they may be previously untreated.  The 
performance score must be 2 or better and the life expectancy must be at least 
2 months; hepatic, renal, and hematopoietic function must be adequate.  There 
shall have been no prior cytotoxic chemotherapy, although corticosteroids are 
allowed.  There may be no previous or concomitant malignancy other than 
curatively treated carcinoma in situ of the cervix or basal cell skin cancer.  
Patients may not be pregnant, nor may they have any serious medical or 
psychiatric illness that would limit survival to less than 5 years.  There may 
be no uncontrolled or severe cardiovascular disease, including myocardial 
infarction within 6 months, congestive heart failure requiring digoxin, or 
documented angina.  There may be no active uncontrolled infection, active 
duodenal ulcer, severe nonneoplastic pulmonary disease, or severe radiation 
pneumonitis.  As per Addendum 1, June 1983, patients in relapse after prior 
radiotherapy with curative intent are eligible at any disease stage, if 
additional radiotherapy for cure cannot be given.

Expected Enrollment

3 years will be required for patient accrual.

Outline

Randomized study.
Arm I:  4-Drug Combination Chemotherapy.  MOPP:  Nitrogen Mustard, NM, 
NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; 
Prednisone, PRED, NSC-10023.
Arm II:  4-Drug Combination Chemotherapy.  ABVD:  Adriamycin, ADR, NSC-123127; 
Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, NSC-45388.
Arm III:  4-Drug Combination Chemotherapy alternating with 4-Drug Combination 
Chemotherapy.  MOPP alternating with ABVD.

Canellos GP, Anderson JR, Propert KJ, et al.: Chemotherapy of advanced Hodgkin's disease with MOPP, ABVD, or MOPP alternating with ABVD. N Engl J Med 327 (21): 1478-84, 1992.[PUBMED Abstract]

Kornblith AB, Anderson J, Cella DF, et al.: Comparison of psychosocial adaptation and sexual function of survivors of advanced Hodgkin disease treated by MOPP, ABVD, or MOPP alternating with ABVD. Cancer 70 (10): 2508-16, 1992.[PUBMED Abstract]

Mir R, Anderson J, Strauchen J, et al.: Hodgkin disease in patients 60 years of age or older. Histologic and clinical features of advanced-stage disease. The Cancer and Leukemia Group B. Cancer 71 (5): 1857-66, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

George Canellos, MD, Protocol chair		Ph: 617-632-3470; 866-790-4500 Email: george_canellos@dfci.harvard.edu