Troglitazone in Treating Patients With Liposarcoma

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: troglitazone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003058

97-075

CDR0000065717

P30CA006516 (U.S. NIH Grant/Contract)

NCI-G97-1313

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Troglitazone

Experimental group

Description:

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.

Treatment:

Drug: troglitazone