Prostate Cancer Clinical Trial
Official title:
PHASE I STUDY OF THE ORALLY ADMINISTERED BUTYRATE PRODRUG, TRIBUTYRIN, IN PATIENTS WITH SOLID TUMORS
Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES:
I. Determine the maximum tolerated dose and optimum schedule of tributyrin in patients with
prostate cancer or other solid tumors.
II. Determine the toxic effects of tributyrin in these patients. III. Determine the
pharmacodynamics of tributyrin, including modulation of tumor markers, evaluation of clinical
remission (when possible), assessment of F-reticulocytes and/or F cells, and evaluation of
hemoglobin F before and after treatment, in these patients.
IV. Determine the pharmacokinetics of tributyrin, including maximum plasma concentration,
terminal half-life, area under the concentration time curve, volume of distribution, and
clearance of butyrate, in these patients.
V. Determine the relationship between the pharmacokinetics and toxic or therapeutic
pharmacodynamic effects of butyrate in these patients.
VI. Calculate a tributyrin dose, using results from pharmacokinetic and pharmacodynamic
studies, that achieves sustained butyrate concentrations capable of increasing therapeutic
effects with reduced toxicity.
OUTLINE: This is a dose escalation study.
Patients receive oral tributyrin every 8 hours for 3 weeks. Treatment continues every 4 weeks
for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who
achieve stable disease may receive additional courses at the discretion of the protocol
chairperson. Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.
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