Perifosine in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00005794|
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : October 19, 2015
RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: perifosine||Phase 1|
- Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
- Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
- Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
- Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading doses 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 6 patients experience dose-limiting toxic effects.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer|
|Study Start Date :||February 2000|
|Study Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005794
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Lynn Van Ummersen, MD||University of Wisconsin, Madison|