Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019656
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
Status:
COMPLETED
Status Verified Date:
2004-08
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 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
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-Hodgkins lymphoma chronic lymphocytic leukemia myelodysplastic syndromes or Hodgkins 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
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-Hodgkins lymphoma chronic lymphocytic leukemia myelodysplastic syndromes or Hodgkins 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
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0065 | None | None | None |
| NCI-99-C-0043 | None | None | None |