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Rosiglitazone in Treating Patients With Liposarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rosiglitazone maleate
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring adult liposarcoma, recurrent adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Well-differentiated liposarcoma

De-differentiated liposarcoma

Myxoid/ round-cell liposarcoma

Pleomorphic liposarcoma

Arm Description

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2000
Last Updated
June 22, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004180
Brief Title
Rosiglitazone in Treating Patients With Liposarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
adult liposarcoma, recurrent adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Well-differentiated liposarcoma
Arm Type
Experimental
Arm Description
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Arm Title
De-differentiated liposarcoma
Arm Type
Experimental
Arm Description
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Arm Title
Myxoid/ round-cell liposarcoma
Arm Type
Experimental
Arm Description
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Arm Title
Pleomorphic liposarcoma
Arm Type
Experimental
Arm Description
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Intervention Type
Drug
Intervention Name(s)
rosiglitazone maleate
Other Intervention Name(s)
Rosiglitazone
Primary Outcome Measure Information:
Title
Evidence of biological response
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George D. Demetri, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rosiglitazone in Treating Patients With Liposarcoma

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