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Troglitazone in Treating Patients With Liposarcoma

Sarcoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003058
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date June 1997
Completion date January 2000
View Details
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