Troglitazone in Treating Patients With Liposarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003058
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: June 2000
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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.

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

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

Additional relevant MeSH terms:
Liposarcoma
Sarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Troglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014