Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00003058
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Troglitazone in Treating Patients With Liposarcoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA006516 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000065717 | None | None | View | |
| NCI-G97-1313 | None | None | View |