Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
- Conditions
- LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00019656
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.
- Detailed Description
OBJECTIVES:
* 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 patients.
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 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
NCI - Center for Cancer Research
🇺🇸Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States