Overview

This trial is active, not recruiting.

Condition sarcoma
Treatment rosiglitazone maleate
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date October 1999
End date March 2006
Trial size 33 participants
Trial identifier NCT00004180, CDR0000067406, DFCI-99083, NCI-G99-1629, P30CA006516

Summary

RATIONALE: Rosiglitazone may help liposarcoma cells develop into normal fat cells.

PURPOSE: Phase II trial to study the effectiveness of rosiglitazone in treating patients who have liposarcoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
rosiglitazone maleate Rosiglitazone
(Experimental)
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
rosiglitazone maleate Rosiglitazone
(Experimental)
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
rosiglitazone maleate Rosiglitazone
(Experimental)
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
rosiglitazone maleate Rosiglitazone

Primary Outcomes

Measure
Evidence of biological response
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.