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Phase III Radiotherapy plus MOPP (NM/VCR/PCB/PRED) and ABVD (ADR/BLEO/VBL/DTIC) for Stage I/II Hodgkin's Disease

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedno age specifiedMDA-RT-8001

Objectives

I.  Improve the overall results of treatment of adults with Hodgkin's disease 
in early stages by utilizing optimal radiotherapy and chemotherapy.
II.  Reduce the acknowledged risk of myelosuppression, sterility, and second 
tumors observed in patients treated with conventional radiotherapy and 
chemotherapy by reducing therapy to the minimal effective dosages.
III.  Design acceptable salvage therapy for patients who relapse after minimal 
therapy, in order to achieve the best possible survival rates.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with Stage I, IE, II, or IIE 
Hodgkin's disease with any histopathology or symptomatology, who have not 
received prior therapy.  Patients must agree to lymphangiogram, laparotomy, 
radiotherapy, and chemotherapy.

Expected Enrollment

Protocol closed in 1982.

Outline

Nonrandomized study.  Patients enter Regimen A if there is limited or medium 
disease, nonmediastinal (good-risk) disease, or UT nodal relapse in an 
unirradiated area following any initial treatment; patients enter Regimen A 
plus Regimen B in the case of extensive involvement, life-threatening disease, 
or poor-risk nonmediastinal disease.  All other patients receive varied 
combinations of Regimens A, B, and C.
Regimen A:  Radiotherapy.  Unspecified source to the involved field (IF), a 
unilateral or bilateral thin lung bloc (TLBI), the total abdomen, and other 
indicated areas.
Regimen B:  3-Drug Combination Chemotherapy plus Steroid Therapy.  MOPP:  
Nitrogen Mustard, NM, NSC-762; Vincristine, Oncovin, VCR, NSC-67574; 
Procarbazine, PCB, NSC-77213; plus Prednisone, PRED, NSC-10023.
Regimen C:  4-Drug Combination Chemotherapy.  ABVD:  Adriamycin, ADR, 
NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842; DTIC, 
NSC-45388.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair
Ph: 713-792-2570; 800-392-1611

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.

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