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	any age	NCI	YALE-HIC-3281 NCI-T85-0116D, T85-0116

Objectives

I.  Determine whether low-dose radiotherapy increases relapse-free or total 
survival in patients with advanced stage Hodgkin's disease who have achieved 
complete responses to alternating non-cross resistant combination chemotherapy 
with MA/MA:  MOPP (mechlorethamine/oncovin/procarbazine/prednisone) 
alternating with ABVD (adriamycin/bleomycin/vinblastine/dacarbazine).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with 
histologically confirmed advanced stage Hodgkin's disease who have not had 
prior therapy or who have relapsed after previous radiotherapy alone.  
Patients with Ann Arbor clinical Stage IIIA (unequivocally positive 
lymphangiograms, CT scans, or palpable biopsy-proven disease above and below 
the diaphragm) and pathologic Stages III (1A or 2A with extensive splenic 
involvement), III2A, IIIB, and IV are eligible.  Previously untreated patients 
of any stage with large mediastinal mass (greater than 0.3 of the greatest 
thoracic diameter) are also eligible, but are not randomized.  Disease must be 
measurable.  Granulocytes and platelets greater than 500/cumm and 
100,000/cumm, respectively, are required.

Expected Enrollment

240 patients are expected to enter over 5 years.

Outline

Randomized study.  Patients without significant mediastinal mass (0.3 of the 
greatest thoracic diameter or less) are randomized to Arms I and II.  Patients 
with mediastinal mass greater than 0.3 of the thoracic diameter are assigned 
to Arm II.
Arm I:  4-Drug Combination Chemotherapy Alternating with 4-Drug Combination 
Chemotherapy.  MA/MA:  MOPP:  Mechlorethamine, 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; 
Dacarbazine, DTIC, NSC-45388.
Arm II:  4-Drug Combination Chemotherapy Alternating with 4-Drug Combination 
Chemotherapy Followed by Radiotherapy.  MA/MA; followed by irradiation of all 
pretreatment sites of disease (except bone marrow) using megavoltage equipment.

Doria R, Holford T, Prosnitz LR, et al.: Second solid tumors (SST) in patients with Hodgkin's disease (HD) after combined modality therapy (CMT). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1246, 369, 1994.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

Dennis Cooper, MD, Protocol chair		Ph: 203-737-5751; 866-925-3226 Email: dennis.coope@yale.edu