Rosiglitazone in Treating Patients With Liposarcoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoma
Intervention: rosiglitazone maleate (Drug); biological therapy (Procedure); differentiation therapy (Procedure)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
George D. Demetri, MD, Study Chair, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
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
Study design: Interventional, Treatment
Detailed 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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
October 1999
Last updated: March 5, 2007
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