Troglitazone in Treating Patients With Liposarcoma
This trial is active, not recruiting.
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 1997|
|Trial size||150 participants|
|Trial identifier||NCT00003058, CDR0000065717, DFCI-97075, NCI-G97-1313|
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.
Male or female participants at least 18 years old.
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
|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|
|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.|
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