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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		UCCRC-2121B NCI-V83-0124

Objectives

I.  Induce remission in pathologically staged patients with Stage 
IA/IB/IIA/IIB/IIIA/IIIB/IVA/IVB Hodgkin's disease.
II.  Increase survival time in patients with advanced Hodgkin's disease.
III.  Evaluate the disease-free survival after extended field radiotherapy in 
patients with Stage IA/IIA/III1A disease.
IV.  Evaluate the disease-free survival after extended field radiotherapy and 
combination chemotherapy in patients with Stage IB/IIB/III1B disease.
V.  Study the results of total nodal radiotherapy and combination chemotherapy 
in patients with Stage III2A/III2B disease.
VI.  Explore drug combinations other than MOPP or COPP in patients with Stage 
IVA/IVB disease.
VII.  Observe the length of complete remission proven by restaging and 
unmaintained by drugs in patients with Stage IVA/IVB disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic diagnosis of 
Hodgkin's disease.  Patients may not have both Hodgkin's disease and another 
lymphoma found in the same or in two different biopsies.  Only pathologically 
staged patients who are either previously untreated or previously treated and 
off therapy for two months or with progressive disease are eligible.  
Previously treated patients with Stage IA/IEA/IIA/IIEA disease are eligible if 
they are eligible for extended field radiotherapy.  Patients with Stage 
IB/IIB/III1B disease are eligible, with the exception of those ineligible for 
extended field radiotherapy or those who failed combination chemotherapy as in 
this protocol or closely related drug regimens.  Patients with Stage 
III2A/III2B are eligible except for those ineligible for total nodal 
radiotherapy or those who failed combination chemotherapy as in this protocol 
or closely related drug regimens.  Patients with extranodal disease 
(documented Stage IE/IIE/IIIE/IIISE) are eligible; the "E" concept is not 
applicable to contiguous involvement of the lung.  Patients with Stage IV 
disease (except for patients who failed combination chemotherapy as in this 
protocol or closely related drug regimens) may be entered but must be analyzed 
separately.  Stage IV disease must be proven by disseminated involvement of 
bone marrow, bone, lung, skin, liver, or other organs.  Two parameters of 
disease must be present for Stage IV (clinical or radiological); liver 
function tests, liver biopsies, and bone marrow biopsy parameters are 
excluded.  Patients who do not qualify for evaluation of remission criteria 
are listed separately for analysis of survival, relapse-free survival, and 
drug toxicity.  Patients initially deemed ineligible for this study may become 
eligible at a later date as their disease evolves; those with recurrent 
disease after one therapeutic approach within a study may subsequently be 
eligible for entry into another track of study.

Expected Enrollment

As of May 1984 the study has been discontinued.

Outline

Nonrandomized study.  Pathologically staged patients are treated as follows:  
Regimen A - Stages IA/IEA/IIA/IIEA (those with "E" in lung are treated as 
Stage B patients); Regimen B - Stage III1A; Regimen C - Stages IB/IIB/III1B; 
Regimen D - Stages III2A/III2B; Regimen E - Stages IVA/IVB.
Regimen A:  Radiotherapy.  Extended field irradiation with 4 MeV linear 
accelerator x-rays.
Regimen B:  Radiotherapy.  Extended mantle irradiation with equipment as in 
Regimen A.
Regimen C:  4-Drug Combination Chemotherapy plus Radiotherapy.  MOPP:  
Nitrogen Mustard, NM, NSC-762; Vincristine, Oncovin, VCR, NSC-67574; 
Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; plus extended 
mantle irradiation with equipment as in Regimen A.
Regimen D:  4-Drug Combination Chemotherapy plus Radiotherapy.  MOPP; plus 
extended mantle and inverted "Y" irradiation with equipment as in Regimen A.
Regimen E:  4-Drug Combination Chemotherapy plus Single-agent Chemotherapy 
with Leucovorin Rescue plus Crossover 4-Drug Combination Chemotherapy.  MOPP; 
plus Methotrexate, MTX, NSC-740; Citrovorum Factor, CF, NSC-3590; plus ABVD:  
Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, 
NSC-49842; DTIC, NSC-45388.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

John Ultmann, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9305 Email: jultmann@medicine.bsd.uchicago.edu