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 Treatment Closed over 18 UMCC-7110

Objectives

I.  Compare daunomycin alone vs. daunomycin/ARA-C/6-thioguanine/pyrimethamine 
for induction therapy in adults with acute nonlymphocytic leukemia.
II.  Determine whether pyrimethamine crosses the blood-brain barrier in 
patients without meningeal disease.
III.  Determine whether pyrimethamine administered to previously untreated 
acute nonlymphocytic leukemia patients without meningeal leukemia prevents or 
delays the onset of meningeal leukemia.
IV.  Determine whether the duration of remission is significantly longer in 
both arms of this study than has previously been true, thus suggesting that 
the cytoreductive phase of the study is efficacious.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated adult patients 
with acute nonlymphocytic leukemia with no evidence of meningeal leukemia and 
normal routine CSF studies.  Patients who have otherwise normal CSF studies 
but show blasts on cytocentrifuge examination are eligible but will be 
evaluated separately.  Kidney and liver function must be normal.

Expected Enrollment

Protocol closed 12/73.

Outline

Randomized study, for Induction only.  Enter all patients on Pre-Induction 
Regimen A.
Regimen A:  Pre-Induction.  Enter patients on Laminar Air Flow Protocol and 
begin Allopurinol, NSC-1390.
Regimen B:  Induction.  Randomize patients to Arm I or Arm II.
Arm I:  Single-agent Chemotherapy.  Daunomycin, DNM, NSC-82151.
Arm II:  4-Drug Combination Chemotherapy.  DNM; ARA-C, NSC-63878; 
6-Thioguanine, TG, NSC-752; Pyrimethamine, NSC-3061.
Regimen C:  Consolidation.  Enter CR from Arm I to Arm III and CR from Arm II 
to Arm IV.
Arm III:  Single-agent Chemotherapy.  DNM.
Arm IV:  4-Drug Combination Chemotherapy.  DNM; ARA-C; TG; Pyrimethamine.
Regimen D:  Cytoreduction Phase.  Enter all patients from Arm III and Arm IV.  
2-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, NSC-26271; Guanazole, 
NSC-1895.
Regimen E:  Maintenance.  Enter patients induced in Arm I to Arm V and those 
induced in Arm II to Arm VI.
Arm V:  Observation only.
Arm VI:  Single-agent Chemotherapy.  Pyrimethamine.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

David Van Echo, MD, Protocol chair(Contact information may not be current)		Ph: 410-328-2665; 800-888-8823 Email: dvanecho@umm.edu