Rosiglitazone in Treating Patients With Liposarcoma
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.
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- 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 myxoid/round 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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||George D. Demetri, MD||Dana-Farber Cancer Institute|