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Troglitazone in Treating Patients With Liposarcoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003058
  Purpose

RATIONALE: Troglitazone may help liposarcoma cells develop into normal cells.

PURPOSE: Phase II trial to study the effectiveness of troglitazone in treating patients with malignant liposarcoma.


Condition Intervention Phase
Sarcoma
Drug: troglitazone
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Troglitazone
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 150
Study Start Date: June 1997
Detailed Description:

OBJECTIVES: I. Evaluate the clinical activity of troglitazone in patients with malignant liposarcoma. II. Evaluate the tolerance and safety of troglitazone in this patient population.

OUTLINE: This is an open label trial. All patients are given a single dose of oral troglitazone daily. Patients continue to receive troglitazone as long as their disease responds to treatment or remains stable.

PROJECTED ACCRUAL: Initially, 14 patients of each of the 5 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 per subtype.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003058

Locations
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
Investigators
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Demetri GD, Fletcher CD, Mueller E, Sarraf P, Naujoks R, Campbell N, Spiegelman BM, Singer S. Induction of solid tumor differentiation by the peroxisome proliferator-activated receptor-gamma ligand troglitazone in patients with liposarcoma. Proc Natl Acad Sci U S A. 1999 Mar 30;96(7):3951-6.
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.

Study ID Numbers: CDR0000065717, DFCI-97075, NCI-G97-1313
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003058  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult liposarcoma
recurrent adult soft tissue sarcoma

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Liposarcoma
Malignant mesenchymal tumor
Troglitazone
Sarcoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
Neoplasms
Hypoglycemic Agents
Neoplasms by Histologic Type
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms, Adipose Tissue

ClinicalTrials.gov processed this record on January 14, 2009