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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed under 18 NCI SJCRH-NMF-I/II NCI-T83-1154D, T83-1154

Objectives

I.  Determine the toxic effects of various dosages of N-methylformamide (N-MF) 
in children with refractory malignant solid tumors and leukemia.
II.  Determine the maximum tolerated doses of N-MF in these patients.
III.  Determine the antitumor effects of N-MF in these patients.
IV.  Assess the differentiation-inducing capacity of N-MF in vitro and in vivo 
by assessing changes in leukocyte markers.
V.  Determine the pharmacokinetics of N-MF in children with cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with an established tissue 
or marrow diagnosis of neuroblastoma or other drug-resistant pediatric 
malignant tumor and those with acute leukemia.  The minimum life expectancy 
must be 4 weeks, and there must be evidence of adequate renal, hepatic, and 
hematopoietic function.  There may have been no chemotherapy within 2 weeks of 
entry, or patients must have recovered from the toxic effects of all prior 
chemotherapy and radiotherapy.  Normal cardiac function must be demonstrated 
by clinical examination and EKG or echocardiogram.

Expected Enrollment

Not given.

Outline

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

Murphy SB, Mirro J, Pui CH, et al.: Phase I trial of N-methylformamide in pediatric patients with refractory leukemias. Cancer Treat Rep 71(12): 1299-1300, 1987.

Trial Contact Information

Trial Lead Organizations

St. Jude Children's Research Hospital

Charles Benton Pratt, MD, Protocol chair(Contact information may not be current)		Ph: 901-495-3442 Email: charles.pratt@stjude.org