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	18 and over		MDA-IM-8007 NCI-V86-0049

Objectives

I.  Improve the overall results of treatment of adults with Hodgkin's disease 
with Stage IIIA and IIIB presentations by utilizing optimal radiotherapy and 
chemotherapy with MOPP (nitrogen mustard/vincristine/procarbazine/prednisone) 
plus ABVD (adriamycin/bleomycin/vinblastine/DTIC), CVPP 
(cyclophosphamide/vinblastine/procarbazine/prednisone), and AB-DIC 
(adriamycin/bleomycin/DTIC/CCNU/prednisone) as salvage therapy for MOPP 
failures.
II.  Reduce acknowledged risk of myelosuppression, sterility, and second 
tumors observed in patients treated with conventional radiotherapy and 
chemotherapy by reducing therapy to the minimum effective dose.
III.  Design acceptable salvage therapy for patients who relapse after 
therapy, in order to improve survival further.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated adult patients 
with Stage IIIA, IIIB, IIIEA, or IIIEB Hodgkin's disease with any 
histopathology.  Patients must agree to lymphangiogram, laparotomy, 
radiotherapy and chemotherapy.  All radiotherapy must be administered at M.D. 
Anderson Hospital; all chemotherapy must be directed by the appropriate M.D. 
Anderson staff.

Expected Enrollment

100 patients will be entered.

Outline

Nonrandomized study.  Patients are initially treated on Regimen A.  The order 
in which the various therapy modalities are administered and the number of 
cycles of Chemotherapy depend upon the disease stage.  Patients who fail to 
respond to Regimen A therapy or relapse during therapy enter Regimen B 
(failing or relapsing during MOPP cycles) or C (failing or relapsing during 
Radiotherapy).
Regimen A:  4-Drug Combination Chemotherapy plus Radiotherapy plus Surgery (as 
appropriate).  MOPP:  Nitrogen Mustard, NM, NSC-762; Vincristine, VCR, 
NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; plus 
tumor irradiation; plus Laparotomy where appropriate.
Regimen B:  4-Drug Combination Chemotherapy.  ABVD:  Adriamycin, ADR, 
NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, 
NSC-45388.
Regimen C:  4-Drug Combination Chemotherapy alternating with 5-Drug 
Combination Chemotherapy.  CVPP:  Cyclophosphamide, CTX, NSC-26271; VBL; PCB; 
PRED; alternating with AB-DIC:  ADR; BLEO; DTIC; CCNU, NSC-79037; PRED.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Fredrick Hagemeister, MD, Protocol chair		Ph: 713-792-2860; 800-392-1611 Email: fhagemei@mail.mdanderson.org