- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004180
Rosiglitazone in Treating Patients With Liposarcoma
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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Well-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
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Other Names:
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Experimental: De-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
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Other Names:
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Experimental: Myxoid/ round-cell liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
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Other Names:
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Experimental: Pleomorphic liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Evidence of biological response
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: George D. Demetri, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067406
- P30CA006516 (U.S. NIH Grant/Contract)
- DFCI-99083 (Other Identifier: Dana-Farber Cancer Institute)
- NCI-G99-1629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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