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Troglitazone in Treating Patients With Liposarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003058
Recruitment Status : Completed
First Posted : August 12, 2004
Last Update Posted : February 13, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Demetri, M.D., Dana-Farber Cancer Institute

Brief Summary:
Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: troglitazone Phase 2

Detailed Description:


I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.

II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.

III. To evaluate the tolerance and safety of troglitazone in this patient population.


Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. If 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of TROGLITAZONE, a Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR), as Antineoplastic Differentiation Therapy for Patients With Malignant Liposarcoma
Study Start Date : June 1997
Actual Primary Completion Date : January 2000
Actual Study Completion Date : January 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Troglitazone
Patients received troglitazone 800 mg oral once-daily. Treatment continued as long as patient was responding or in stable disease clinically and ended if patient experienced progression or unacceptable toxicity.
Drug: troglitazone
Other Name: Rezulin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard surgery Measurable or evaluable disease required No active CNS involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No known active retroviral disease

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy for metastatic disease allowed No radiotherapy to sole site of measurable disease within past 6 months Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003058

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
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Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
Publications of Results:
Demetri GD, Spiegelman B, Fletcher CD, et al.: Differentiation of liposarcomas in patients treated with the PPAR g ligand troglitazone: documentation of biologic activity in myxoid/round cell and pleomorphic subtypes. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2064, 535a, 1999.

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Responsible Party: George Demetri, M.D., Demetri, George MD, Dana-Farber Cancer Institute Identifier: NCT00003058    
Other Study ID Numbers: 97-075
P30CA006516 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2004    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by George Demetri, M.D., Dana-Farber Cancer Institute:
adult liposarcoma
recurrent adult soft tissue sarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Hypoglycemic Agents
Physiological Effects of Drugs