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 over 18 NCI CRB-8807E NCI-87-C-180C, NCI-T87-0307N, T87-0307

Objectives

I.  Assess the CR rate, duration of remission, and long-term survival of 
previously untreated patients with advanced stages of diffuse lymphoma treated 
with short-course ProMACE-CytaBOM and compare these results with those of 
age-, stage-, and sex-matched patients treated with conventional 
ProMACE-CytaBOM on protocol NCI-MB-161.

II.  Calculate the dose-intensity of drugs actually delivered with 
short-course ProMACE-CytaBOM and compare it to that of age-, stage-, and 
sex-matched patients treated with conventional ProMACE-CytaBOM.

Entry Criteria

Disease Characteristics:

Stage II-IV diffuse lymphoma of one of the following histologic types as
confirmed by the NCI Laboratory of Pathology:
  Follicular large cell (Rappaport NHL)
  Follicular mixed (Rappaport NML)
  Diffuse mixed (Rappaport DML)
  Diffuse large cell (cleaved or noncleaved) (Rappaport DHL)
  Diffuse immunoblastic (Rappaport DHL)

DML acceptable provided any single biopsy site is at least 50% diffuse

Prior/Concurrent Therapy:

Absence of prior therapy preferred

Biologic therapy:
  Not specified

Chemotherapy:
  Not specified

Endocrine therapy:
  Short course of steroid therapy for superior vena caval obstruction is
  allowed

Radiotherapy:
  Relapse following limited prior radiotherapy allowed

Surgery:
  Not specified

Patient Characteristics:

Age:
  Over 18

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No other major medical illness that would preclude safe administration of
     protocol chemotherapy
  HIV seronegative
  Hepatitis B seronegative

Expected Enrollment

80 patients will be entered.  A cohort of non-dose-escalated patients will be 
entered initially and a cohort of dose-escalated patients will be analyzed 
separately and together for response and dose intensity.  Also, patients with 
follicular mixed cell lymphoma will be analyzed separately from other 
histologies.

Outline

3-Drug Combination Chemotherapy Alternating with 4-Drug Combination 
Chemotherapy with Leukovorin Rescue plus Intermittent Single-agent 
Chemotherapy plus Antibiotic Prophylaxis.  Short-course ProMACE-CytaBOM:  
Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Etoposide, 
VP-16, NSC-141540; alternating weekly with Cytosine arabinoside, ARA-C, 
NSC-63878; Bleomycin, BLEO, NSC-125066; Vincristine, VCR, NSC-67574; 
Methotrexate, MTX, NSC-740; with Citrovorum Factor, CF, NSC-3590; plus 
Prednisone, PRED, NSC-10023; plus Trimethoprim-sulfamethoxazole, Bactrim or 
aerosolized Pentamidine.

Trial Contact Information

Trial Lead Organizations

Clinical Research Branch

Barry Gause, MD, Protocol chair		Ph: 301-594-9829 Email: gauseb@mail.nih.gov