A PHASE I AND PHARMACOLOGICAL STUDY OF PENCLOMEDINE (NSC#338720, IND#43409) ADMINISTERED DAILY BY MOUTH FOR FIVE CONSECUTIVE DAYS IN PATIENTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
OBJECTIVES: I. Determine the maximum tolerated dose of oral penclomedine that can be
administered daily for 5 days every 4 weeks in patients with advanced solid tumor
malignancies. II. Describe and quantitate the toxic effects of penclomedine administered on
this schedule in these patients. III. Study the clinical pharmacology and metabolism of
penclomedine on this schedule, and seek pharmacodynamic correlates of pharmacologic
parameters with clinical endpoints. IV. Study the bioavailability of oral penclomedine, and
qualitatively compare metabolite profiles produced following oral and intravenous
administration in these patients. V. Seek preliminary evidence of therapeutic activity of
penclomedine in patients with advanced cancer.
OUTLINE: This is a dose-escalation study to estimate the maximum tolerated dose (MTD) of
penclomedine. Cohorts of 3-6 patients are treated at escalating doses until the MTD is
reached. Patients receive oral penclomedine for 5 consecutive days every 4 weeks. If tumor
progression or unacceptable toxicity is documented during any treatment course, the patient
is removed from study. A total of 10 patients will be treated at the dose determined to be
the MTD (the recommended phase II dose).
PROJECTED ACCRUAL: An estimated 20 patients will be accrued over approximately 10 months.
Primary Purpose: Treatment
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|