Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy
This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES:
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
dose-limiting toxicity.
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
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