A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
- Determine the dose-limiting toxicity and maximum tolerated dose of perifosine
administered as a varying series of loading and maintenance doses in patients with
refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia,
myelodysplastic syndromes, or Hodgkin's lymphoma.
- Determine the profile of adverse reactions (including changes in laboratory parameters)
in patients treated with this regimen.
- Determine any disease responses that may occur in patients treated with this regimen.
- Determine the steady-state pharmacology and pharmacokinetics of this regimen in these
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose
2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28
days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until
the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once
the MTD is determined, an additional 10 patients are treated at that dose level.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Edward A. Sausville, MD, PhD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|