Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

George Daniel Demetri

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004180
Information obtained from ClinicalTrials.gov on December 14, 2011

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