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Rosiglitazone in Treating Patients With Liposarcoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Demetri, M.D., Dana-Farber Cancer Institute Identifier:
First received: January 21, 2000
Last updated: February 9, 2017
Last verified: February 2017

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.

Condition Intervention Phase
Drug: rosiglitazone maleate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

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.

Enrollment: 32
Study Start Date: October 1999
Study Completion Date: May 2015
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Well-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: Rosiglitazone
Experimental: De-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: Rosiglitazone
Experimental: Myxoid/ round-cell liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: Rosiglitazone
Experimental: Pleomorphic liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: Rosiglitazone

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 90,000/mm3


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT less than 5 times upper limit of normal


  • Creatinine no greater than 2.4 mg/dL


  • 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


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Prior chemotherapy allowed and recovered
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • No concurrent hormonal therapy


  • 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


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004180

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: George Demetri, M.D., Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00004180     History of Changes
Other Study ID Numbers: CDR0000067406
P30CA006516 ( US NIH Grant/Contract Award Number )
DFCI-99083 ( Other Identifier: Dana-Farber Cancer Institute )
Study First Received: January 21, 2000
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
adult liposarcoma
recurrent adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Maleic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017