Phase II Clinical Trial of Rosiglitazone, a Full-Agonist Ligand for the Peroxisome Proliferator-Activated Receptor Gamma (PPAR), as Differentiation Therapy for Patients With Liposarcoma
rosiglitazone maleate
+ rosiglitazone maleate
+ rosiglitazone maleate
Neoplasms+3
+ Neoplasms by Histologic Type
+ Neoplasms, Connective and Soft Tissue
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the clinical activity of rosiglitazone in patients with liposarcoma. Assess the impact of this regimen on markers of tumor proliferation and differentiation status in these patients using biologic and biochemical testing and correlative imaging. Determine the tolerance and safety of this regimen in these patients. OUTLINE: Patients are stratified by histologic subtype (well differentiated vs dedifferentiated vs myxoid/round cell vs pleomorphic). Patients receive oral rosiglitazone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 1-3 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 56-120 patients (14-30 per stratum) will be accrued for this study within 15 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable with standard multimodality approaches (e.g., surgery and/or radiotherapy and/or chemotherapy) Well differentiated OR Dedifferentiated OR Myxoid/round cell OR Pleomorphic Measurable disease No clinically unstable brain metastases No progression on prior troglitazone therapy for liposarcoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper limit of normal Renal: Creatinine no greater than 2.4 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 4 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception Oral contraceptives are not considered effective contraception No active retroviral disease No condition that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior chemotherapy allowed and recovered No concurrent cytotoxic therapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Prior radiotherapy allowed and recovered At least 6 months since prior radiotherapy to the sole site of measurable disease Concurrent localized radiotherapy to a single site of disease allowed if there are other sites of measurable disease Surgery: Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location