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Phase III Alternating MOPP (NM/VCR/PCB/PRED) and CABS (SZC/CCNU/ADR/BLEO) vs MOPP Alone for Stage III/IV Hodgkin's Disease

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 Completed 15 and over NCI-78-C-118
UMCC-7808, NCI-MB-114, NCI-T83-0983, T83-0983

Objectives

I.  Determine whether alternating chemotherapy with MOPP (nitrogen 
mustard/vincristine/procarbazine/prednisone) and CABS 
(streptozotocin/CCNU/adriamycin/bleomycin) offers any significant advantages 
over therapy with MOPP alone in patients with advanced Hodgkin's disease.
II.  Determine whether toxicities of the alternating combinations are greater 
than with MOPP alone.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 15 years of age 
with biopsy-proven Stage III2A, IIIB, and IV Hodgkin's disease who have not 
received prior chemotherapy.  Patients may not have received prior 
radiotherapy to the thorax and must have a vital capacity or diffusion 
capacity of at least 75 percent of predicted values if the deficit results 
from something other than underlying Hodgkin's disease.  Per October 1983 
revision, patients with Stage IIIA1 disease, formerly treated on protocol 
NCI-MB-ROB-133 are now entered on this study.

Expected Enrollment

A total of 157 patients will be randomized.

Outline

Randomized study.
Arm I:  4-Drug Combination Chemotherapy alternating with 4-Drug Combination 
Chemotherapy.  MOPP:  Nitrogen Mustard, NM, NSC-762; Vincristine, VCR, 
NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; 
alternating with CABS:  Streptozotocin, SZC, NSC-85998; CCNU, NSC-79037; 
Adriamycin, ADR, NSC-123127; Bleomycin, BLEO, NSC-125066.
Arm II:  4-Drug Combination Chemotherapy.  MOPP.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Dan Longo, MD, FACP, Protocol chair
Ph: 410-558-8190

Greenebaum Cancer Center at University of Maryland Medical Center

Richard Kaplan, MD, Protocol chair(Contact information may not be current)
Ph: 301-496-2522
Email: kaplanr@ctep.nci.nih.gov

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.