Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084812
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2004-06-10
Brief Title:
Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Open-Labeled Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-03
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 such as cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor
PURPOSE This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors
Secondary
Determine the toxic effects of this regimen in these patients
Determine the clinical pharmacokinetics of this regimen in these patients
Determine preliminarily the therapeutic activity of this regimen in these patients
Determine a safe dose ie near the MTD for phase II evaluation of this regimen in these patients
Determine preliminarily the role of ceramide and S1P relative to response and apoptosis in patients treated with this regimen
OUTLINE This is an open-label non-randomized dose-escalation study of safingol
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only course 1 is 28 days in duration
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose MTD 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 10 additional patients are treated at that dose level
Primary
Determine the maximum tolerated dose MTD of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors
Secondary
Determine the toxic effects of this regimen in these patients
Determine the clinical pharmacokinetics of this regimen in these patients
Determine preliminarily the therapeutic activity of this regimen in these patients
Determine a safe dose ie near the MTD for phase II evaluation of this regimen in these patients
Determine preliminarily the role of ceramide and S1P relative to response and apoptosis in patients treated with this regimen
OUTLINE This is an open-label non-randomized dose-escalation study of safingol
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only course 1 is 28 days in duration
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose MTD 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 10 additional patients are treated at that dose level
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 |
|---|---|---|---|
| MSKCC-04002 | None | None | None |