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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 18 and over NCI ICC-86H3 NCI-T85-0216D, T85-0216

Objectives

I.  Determine the effect of N-methylformamide, in terms of tumor burden and 
response, and estimate the maximum tolerated dose of N-methylformamide in 
patients with previously untreated chronic myelogenous leukemia.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients at 
least 18 years of age with chronic myelogenous leukemia documented by all of 
the following:  presence of the Philadelphia chromosome (Ph-1; 9:21 
translocation), low or absent leukocyte alkaline phosphatase (LAP) score, 
hypercellular bone marrow with an M/E ratio of 10:1 to 50:1, white blood cell 
count greater than 20,000/cumm, peripheral myeloblasts and promyelocytes less 
than 10% of the total white count, palpable spleen, and absence of 
accelerating phase and blastic transformation.  Hepatomegaly and an elevated 
B12 binding capacity are suggestive of CML and should be looked for and 
recorded if present, but they are not necessary for eligibility.  There must 
be no chromosome karyotype demonstrating aneuploidy or multiple Ph-1 
chromosomes.  An ECOG performance status of 0, 1, or 2 is required, as are a 
white blood cell count above 20,000/cumm but not exceeding 300,000/cumm, and 
normal liver and renal function (bilirubin no higher than 1.6 mg%, SGOT no 
greater than 150 IU/ml, serum creatinine at most 2.0 mg%).  Pregnancy 
excludes.  Patients must be free of infection and off antibiotics for at least 
7 days prior to entry on study.

Expected Enrollment

A minimum of 15 patients will be evaluated; if any objective responses are 
observed, a total of 30 patients will be evaluated.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  N-Methylformamide, NMF, NSC-3051.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Omer Kucuk, MD, Protocol chair(Contact information may not be current)		Ph: 312-908-5250