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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed no age specified NCI MSKCC-8376A NCI-T83-1151C, T83-1151

Objectives

I.  Determine the therapeutic efficacy of N-methylformamide in the treatment 
of patients with nonresectable advanced hypernephroma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed advanced nonresectable renal cell carcinoma who have a Karnofsky 
performance status of at least 50 percent and a life expectancy of greater 
than 6 weeks.  There must be adequate hematopoietic, hepatic, and renal 
function and no evidence of ischemic heart disease (New York Heart Association 
functional class III/IV).  There may have been no radiotherapy or chemotherapy 
within 3 weeks of entry (6 weeks for nitrosoureas) and no prior radical 
radiotherapy (4,000 rads to the whole pelvis, 6,000 rads to the bladder).

Expected Enrollment

Initially 19 patients, of whom at least 14 will be previously untreated, will 
be entered.  In the event of a major response, up to 25-40 patients will be 
entered.  Protocol closed May 1985.

Outline

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

Sternberg CN, Yagoda A, Scher HI, et al.: Phase II trial of N-methylformamide for advanced renal cell carcinoma. Cancer Treat Rep 70(5): 681-682, 1986.

Yagoda A, Sternberg C, Scher H, et al.: Phase II trial of N-methylformamide (NMF) in patients with renal cell carcinoma (RCC). [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-408, 105, 1985.

Sternberg CN, Yagoda A: N-methylformamide-induced hypophosphatemia. Cancer Treat Rep 69 (3): 343-4, 1985.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Violante Currie, MD, Protocol chair		Ph: 212-639-6991; 800-525-2225