Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy
I. Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea
in patients with advanced malignancy.
II. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral benzoylphenylurea weekly for 6 weeks. Courses repeat every 8 weeks in
the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive
escalating doses of benzoylphenylurea until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) defined as the highest dose level where 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|