Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Rosiglitazone in Treating Patients With Liposarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	DFCI-99083 NCI-G99-1629, NCT00004180

Objectives

1. Determine the clinical activity of rosiglitazone in patients with liposarcoma.
2. 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.
3. Determine the tolerance and safety of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

A total of 56-120 patients (14-30 per stratum) will be accrued for this study within 15 months.

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.

Trial Contact Information

Trial Lead Organizations

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

George Demetri, MD, Protocol chair		Ph: 617-632-3985; 866-790-4500 Email: gdemetri@partners.org

Registry Information
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
Trial Start Date		1999-10-16
Registered in ClinicalTrials.gov		NCT00004180
Date Submitted to PDQ		1999-10-28
Information Last Verified		2002-12-03
NCI Grant/Contract Number		P30-CA06516

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