Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 3:36 AM
Study NCT ID:
NCT00005794
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perifosine in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
Detailed Description:
OBJECTIVES:
* 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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: