Rosiglitazone in Treating Patients With Liposarcoma

Phase 2

Completed

• Conditions: Sarcoma
• Interventions: Drug: rosiglitazone maleate

• Registration Number: NCT00004180
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2000-01-21
• Study First Submitted QC: 2003-05-08
• Study First Posted: 2003-05-09
• Primary Completion: 2006-03
• Study Completion: 2015-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myxoid/ round-cell liposarcoma	rosiglitazone maleate	Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
De-differentiated liposarcoma	rosiglitazone maleate	Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Pleomorphic liposarcoma	rosiglitazone maleate	Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Well-differentiated liposarcoma	rosiglitazone maleate	Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States