Rosiglitazone in Treating Patients With Liposarcoma

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004180
• Other study ID #: CDR0000067406
• Secondary ID: P30CA006516DFCI-
• Status: Completed
• Phase: Phase 2
• Start date: October 1999
• Est. completion date: May 2015

Study information

• Verified date: June 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liposarcoma
• Sarcoma

Intervention

Drug:
• rosiglitazone maleate

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of biological response	Evidence of biological response can be measured or defined by intracytoplasmic microvesicular lipid accumulation, consistent with adipocytic differentiation in liposarcoma cells. Biological response can also be measured by clinically stable disease for x>3 months, as well as standard clinical trial criteria for "objective clinical response." Complete response is defined by total resolution of all detectable disease lasting for at least four weeks. Partial remission is a decrease of over 50% in the sum of the products of the largest perpendicular diameters of all measurable lesions, persisting for at least four weeks, without progression of any non-measurable sites, and without appearance of any new sites of disease.