Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005794
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2000-06-02
Brief Title:
Perifosine in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase I Trial of Perifosine on a Loading DoseMaintenance 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 dosemaintenance 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 dosemaintenance 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067752 | OTHER | UWCCC Unknown | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-99906 | None | None | None |
| ASTA-D-21266 | None | None | None |
| NCI-T99-0036 | None | None | None |