Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004180
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2000-01-21
Brief Title:
Rosiglitazone in Treating Patients With Liposarcoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Clinical Trial of Rosiglitazone a Full-Agonist Ligand for the Peroxisome Proliferator-Activated Receptor Gamma PPAR as Differentiation Therapy for Patients With Liposarcoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Rosiglitazone may help liposarcoma cells develop into normal fat cells
PURPOSE Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma
PURPOSE Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma
Detailed Description:
OBJECTIVES
Determine the clinical activity of rosiglitazone in patients with liposarcoma
Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging
Determine the tolerance and safety of this regimen in these patients
OUTLINE Patients are stratified by histologic subtype well differentiated vs dedifferentiated vs myxoidround cell vs pleomorphic
Patients receive oral rosiglitazone twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1-3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 56-120 patients 14-30 per stratum will be accrued for this study within 15 months
Determine the clinical activity of rosiglitazone in patients with liposarcoma
Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging
Determine the tolerance and safety of this regimen in these patients
OUTLINE Patients are stratified by histologic subtype well differentiated vs dedifferentiated vs myxoidround cell vs pleomorphic
Patients receive oral rosiglitazone twice daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1-3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 56-120 patients 14-30 per stratum will be accrued for this study within 15 months
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 |
|---|---|---|---|
| NCI-G99-1629 | Other Identifier | Dana-Farber Cancer Institute | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| DFCI-99083 | OTHER | None | None |