Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003058
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
1999-11-01
Brief Title:
Troglitazone in Treating Patients With Liposarcoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Clinical Trial of TROGLITAZONE a Ligand for the Peroxisome Proliferator-Activated Receptor Gamma PPAR as Antineoplastic Differentiation Therapy for Patients With Malignant Liposarcoma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Troglitazone may help liposarcoma cells develop into normal cells This was a single arm open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype
Detailed Description:
OBJECTIVES
I To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype
II To perform correlative imaging biological and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention
III To evaluate the tolerance and safety of troglitazone in this patient population
PROJECTED ACCRUAL
Initially 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued If 1 or more patients show evidence of biological response an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype
I To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype
II To perform correlative imaging biological and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention
III To evaluate the tolerance and safety of troglitazone in this patient population
PROJECTED ACCRUAL
Initially 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued If 1 or more patients show evidence of biological response an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype
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-G97-1313 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| CDR0000065717 | None | None | None |