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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003058 |
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 |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | June 1997 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
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 |
adult liposarcoma recurrent adult soft tissue sarcoma |
Neoplasms, Connective and Soft Tissue Liposarcoma Malignant mesenchymal tumor Troglitazone |
Sarcoma Soft tissue sarcomas Recurrence |
Neoplasms Hypoglycemic Agents Neoplasms by Histologic Type |
Physiological Effects of Drugs Pharmacologic Actions Neoplasms, Adipose Tissue |