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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004180 |
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 |
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Sarcoma |
Drug: rosiglitazone maleate |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
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)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000067406, DFCI-99083, NCI-G99-1629 |
Study First Received: | January 21, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004180 History of Changes |
Health Authority: | United States: Federal Government |
adult liposarcoma recurrent adult soft tissue sarcoma |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Liposarcoma |
Hypoglycemic Agents Sarcoma Rosiglitazone Recurrence |
Neoplasms, Connective and Soft Tissue Neoplasms Liposarcoma Hypoglycemic Agents Neoplasms by Histologic Type |
Physiological Effects of Drugs Sarcoma Rosiglitazone Pharmacologic Actions Neoplasms, Adipose Tissue |