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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006516 | U.S. NIH Grant/Contract | View source | |
| DFCI-99083 | Other Identifier | Dana-Farber Cancer Institute | |
| NCI-G99-1629 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Well-differentiated liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
|
| De-differentiated liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
|
| Myxoid/ round-cell liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
|
| Pleomorphic liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone maleate | Drug |
|
| 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. |
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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)
Measurable disease
No clinically unstable brain metastases
No progression on prior troglitazone therapy for liposarcoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No active retroviral disease
No condition that would preclude informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| George D. Demetri, MD | Dana-Farber Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018205 | Neoplasms, Adipose Tissue |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |