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Phase II-III Chemotherapy with BLEO/DTIC/VBL/ADR/PRED or NM/VCR/PCB/PRED Plus Radiotherapy for Advanced 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, Phase II


Treatment


Closed


no age specified





DFCI-75100


Objectives

I.  Compare the remission-induction capability of BAVIP (bleomycin, DTIC, 
vinblastine, adriamycin, prednisone) vs. MOPP (nitrogen mustard, vincristine, 
procarbazine, prednisone).
II.  Determine if the complete remission rate and disease-free survival can be 
improved by the sequential use of two remission-induction regimens, MOPP and 
BAVIP.
III.  Determine the effectiveness and tolerability of intensive chemotherapy 
for 12 months followed by radiation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Advanced Hodgkin's disease, 
previously untreated by chemotherapy, Stages IVA or IVB.  Stages IIB and IIIB 
are eligible in specific circumstances, but are separately stratified and 
randomized.  Staging must be by lymphangiogram and laparoscopy, histological 
classification (Lukes-Butler systems) reviewed at the DFCI.

Expected Enrollment

Protocol closed 09/78.

Outline

Randomized study.
Arm I:  Sequential Combination Chemotherapy and Hormone Therapy with MOPP, 
followed by BAVIP, followed by Radiotherapy.  MOPP - Nitrogen mustard, NM, 
NSC-762; Vincristine, VCR, NSC-67574; Procarbazine (PCB, NSC-77213); 
Prednisone, PRED, NSC-10023; followed by BAVIP - Bleomycin, BLEO, NSC-125066; 
DTIC, NSC-45388; Vinblastine, VBL, NSC-49642; Adriamycin, ADR, NSC-123127; 
Prednisone,(PRED, NSC-10023, followed by radiotherapy for patients in complete 
remission.
Arm II:  Sequential Combination Chemotherapy and Hormone Therapy with BAVIP 
followed by MOPP followed by radiotherapy.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Emil Frei, MD, Protocol chair(Contact information may not be current)
Ph: 617-632-3474; 866-790-4500

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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