Rosiglitazone in Treating Patients With Liposarcoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: rosiglitazone maleate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 Start Date: | October 1999 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | George Demetri, M.D., Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00004180 History of Changes |
| Other Study ID Numbers: | CDR0000067406, P30CA006516, DFCI-99083, NCI-G99-1629 |
| Study First Received: | January 21, 2000 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dana-Farber Cancer Institute:
|
adult liposarcoma recurrent adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Liposarcoma Sarcoma Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Maleic acid |
Rosiglitazone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013