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Chemotherapy with CHOP-BLEO plus Maintenance with OAP in PEPA Program for Diffuse Histiocytic Lymphoma

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Supportive care, Treatment

Closed

15 to 65

MDA-DT-7806

Objectives

I.  Determine whether higher doses of chemotherapy with CHOP-BLEO:  
cyclophosphamide (CTX), adriamycin (ADR), vincristine (VCR), prednisone (PRED) 
and bleomycin (BLEO) administered in the Protected Environment Prophylactic 
Antibiotic (PEPA) Program will produce the optimum complete remission rate and 
longer disease-free survival.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 15 to 65 years old with 
measurable, biopsy-confirmed diffuse histiocytic lymphoma Stage III or IV 
without prior chemotherapy or CNS disease at diagnosis, and with adequate 
cardiac status.

Expected Enrollment

About 40 patients will be entered in about 4 years.  Protocol closed March 1981.

Outline

Nonrandomized study.  All patients receive prophylactic antibiotic therapy 
consisting of tobramycin, vancomycin, nystatin, and 5-fluorocytosine; 48 hours 
after the onset of this therapy, patients enter PEPA and begin Induction 
therapy.
Induction:  5-Drug Combination Chemotherapy.  CHOP-BLEO:  Cyclophosphamide, 
CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Vincristine, VCR, NSC-67574; 
Prednisone, PRED, NSC-10023; Bleomycin, BLEO, NSC-125066.
Maintenance:  3-Drug Combination Chemotherapy.  OAP:  VCR; Cytosine 
arabinoside, ARA-C, NSC-63878; PRED.

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.