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
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 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.
Interventional
Primary Purpose: Treatment
George D. Demetri, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000067406
NCT00004180
October 1999
December 2013
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |