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-3954 NCI-V84-0038

Objectives

I.  Standardize diagnostic and staging procedures in order to define 
appropriate groups of patients with Hodgkin's disease for further study of the 
efficacy of appropriate treatment regimens.
II.  Induce remission in patients with Hodgkin's disease through the use of 
specific treatment regimens appropriate for the stage of the disease:  
extended mantle or inverted Y radiotherapy for previously untreated patients 
with pathologic Stage IA, IIA, or III-1-A disease and MOPP (nitrogen 
mustard/vincristine/procarbazine/prednisone) alone or alternating with ABVD 
(adriamycin/bleomycin/vinblastine/DTIC) for all other previously untreated 
patients.
III.  Induce remission in various subsets of patients with recurrent Hodgkin's 
disease following radiotherapy or combination chemotherapy utilizing MOPP, 
ABVD, or alternating courses of MOPP and ABVD.
IV.  Determine for each stage of disease the disease-free survival and 
remission frequency in patients with measurable disease and total survival in 
patients with both measurable and nonmeasurable disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

All patients with Hodgkin's disease 
verified by histologic review at the University of Chicago provided they have 
been fully staged clinically and/or pathologically.  Patients with extranodal 
disease are eligible.  Stage IV disease must be proven by documented 
involvement of bone marrow, bone, lung, skin, liver, or other organs.  While 
measurable or evaluable parameters of disease activity are not required for 
entry, such parameters are desirable and are required for evaluation of CR or 
PR; patients without such parameters will be evaluated only for total 
survival.  Newly referred patients should not have received chemotherapy or 
radiotherapy during the 2 months prior to entry.  However, the presence of 
progressive disease during such therapy permits valid assessment of areas 
involved with disease and makes such patients eligible for appropriate 
protocol therapy.  Patients with recurrent disease after one therapeutic trial 
in this or another study may be eligible for another therapeutic trial within 
the study.  Patients who have failed the same or a similar drug regimen as 
outlined in this protocol are ineligible for that portion of this protocol.  
Patients must be free of serious underlying medical conditions that would 
contraindicate treatment on protocol and may have no other malignancy except 
skin cancer and surgically treated Stage I cervical cancer.  There may be no 
non-Hodgkin's lymphoma coexisting with Hodgkin's disease.

Expected Enrollment

Not given.

Outline

Nonrandomized study.  Previously untreated patients with pathological Stage 
IA, IIA, III1A with fewer than 5 splenic nodules, IB, or IIB disease are 
treated on Regimen A; all other previously untreated patients, including all 
those with bulky mediastinal disease or continguous involvement of the lung 
(E) and all patients with Stage III1A disease with 5 or more splenic nodules, 
are treated on Regimen B or D.  Patients with recurrent or disseminated 
disease after previous radiotherapy are treated on Regimen B and enrolled in 
CALGB protocols (if eligible), as are patients with a marginal recurrence 
after previous radiotherapy who were not treated at the University of Chicago; 
patients with a marginal recurrence after previous radiotherapy given at the 
University of Chicago are treated on Regimen A, if feasible.  Patients 
recurrent more than one year after previous chemotherapy with MOPP, ABVD, or 
MOPP/ABVD are treated on Regimen B.  Patients recurrent less than one year 
after or failing to achieve remission after therapy with MOPP or ABVD are 
treated on Regimens C and D, respectively; patients recurrent less than one 
year after or failing to achieve remission after therapy with MOPP/ABVD or any 
of the above regimens are treated on the Developmental Drug Program.
Regimen A:  Radiotherapy.  Extended field irradiation (equipment unspecified).
Regimen B:  4-Drug Combination Chemotherapy Alternating with 4-Drug 
Combination Chemotherapy plus (if indicated) Radiotherapy.  MOPP:  Nitrogen 
Mustard, NM, NSC-762; Oncovin, 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; plus (if indicated) irradiation of potential or remaining 
residual disease.
Regimen C:  4-Drug Combination Chemotherapy.  ABVD.
Regimen D:  4-Drug Combination Chemotherapy plus (if indicated) Radiotherapy.  
MOPP; plus irradiation as in Regimen B.
Developmental Drug Program:  Various treatments.

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