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Troglitazone in Treating Patients With Liposarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003058
First Posted: August 12, 2004
Last Update Posted: February 13, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Demetri, M.D., Dana-Farber Cancer Institute
November 1, 1999
August 12, 2004
February 13, 2017
June 1997
January 2000   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003058 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Troglitazone in Treating Patients With Liposarcoma
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
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.

OBJECTIVES:

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.

PROJECTED ACCRUAL:

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma
Drug: troglitazone
Other Name: Rezulin
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.
Intervention: Drug: troglitazone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
January 2000
January 2000   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003058
97-075
P30CA006516 ( U.S. NIH Grant/Contract )
CDR0000065717
NCI-G97-1313
Yes
Not Provided
Plan to Share IPD: No
George Demetri, M.D., Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP