Rosiglitazone in Treating Patients With Liposarcoma

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: rosiglitazone maleate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004180

NCI-G99-1629

P30CA006516 (U.S. NIH Grant/Contract)

CDR0000067406

DFCI-99083 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Well-differentiated liposarcoma

Experimental group

Description:

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Treatment:

Drug: rosiglitazone maleate

De-differentiated liposarcoma

Experimental group

Description:

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Treatment:

Drug: rosiglitazone maleate

Myxoid/ round-cell liposarcoma

Experimental group

Description:

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Treatment:

Drug: rosiglitazone maleate

Pleomorphic liposarcoma

Experimental group

Description:

Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.

Treatment:

Drug: rosiglitazone maleate