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 Treatment Completed over 15 NCI UMCC-8308 NCI-T83-1081W, T83-1081

Objectives

I.  Determine the objective remission rate, duration of remission, and 
survival among patients with advanced renal cell carcinoma treated with 
N-methylformamide.
II.  Further evaluate toxicity associated with this treatment.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over the age of 15 years 
with histologically documented, measurable renal cell carcinoma, Stage III or 
IV, provided there has been no previous exposure to cytotoxic chemotherapy.  
The CALGB performance score must be 0-2 and the life expectancy greater than 2 
months.  More than 4 weeks must have elapsed since prior radiotherapy, 
immunotherapy, or hormonal therapy, and more than 2 weeks since surgery.  
Efforts will be made to enroll patients who have not received any prior 
therapy.  Liver, kidney, and bone marrow function must be adequate, and 
patients must be able to sustain adequate nutrition.  There may have been no 
previous or concomitant second malignancy except for curatively treated 
carcinoma in situ of the cervix or basal cell carcinoma of the skin.  Patients 
must be free of concurrent infection.

Expected Enrollment

If there is any response among the first 20 patients, at least 40 evaluable 
patients will be entered.

Outline

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

Abrams JS, Tait N, Silva H, et al.: Phase II trial of N-methylformamide in advanced renal cancer. Am J Clin Oncol 12 (1): 41-2, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Jeffrey Abrams, MD, Protocol chair		Ph: 301-496-2522 Email: abramsj@ctep.nci.nih.gov