Rosiglitazone in Treating Patients With Liposarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: rosiglitazone maleate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable with standard multimodality approaches (e.g., surgery and/or radiotherapy and/or chemotherapy) Well differentiated OR Dedifferentiated OR Myxoid/round cell OR Pleomorphic Measurable disease No clinically unstable brain metastases No progression on prior troglitazone therapy for liposarcoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper limit of normal Renal: Creatinine no greater than 2.4 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 4 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception Oral contraceptives are not considered effective contraception No active retroviral disease No condition that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior chemotherapy allowed and recovered No concurrent cytotoxic therapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Prior radiotherapy allowed and recovered At least 6 months since prior radiotherapy to the sole site of measurable disease Concurrent localized radiotherapy to a single site of disease allowed if there are other sites of measurable disease Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Well-differentiated liposarcoma<br>Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. | Drug: rosiglitazone maleate<br> <br> * Other names: Rosiglitazone;|
| Experimental: De-differentiated liposarcoma<br>Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. | Drug: rosiglitazone maleate<br> <br> * Other names: Rosiglitazone;|
| Experimental: Myxoid/ round-cell liposarcoma<br>Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. | Drug: rosiglitazone maleate<br> <br> * Other names: Rosiglitazone;|
| Experimental: Pleomorphic liposarcoma<br>Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. | Drug: rosiglitazone maleate<br> <br> * Other names: Rosiglitazone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of biological response | Evidence of biological response can be measured or defined by intracytoplasmic microvesicular lipid accumulation, consistent with adipocytic differentiation in liposarcoma cells. Biological response can also be measured by clinically stable disease for x>3 months, as well as standard clinical trial criteria for objective clinical response. Complete response is defined by total resolution of all detectable disease lasting for at least four weeks. Partial remission is a decrease of over 50% in the sum of the products of the largest perpendicular diameters of all measurable lesions, persisting for at least four weeks, without progression of any non-measurable sites, and without appearance of any new sites of disease. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult liposarcoma, recurrent adult soft tissue sarcoma