Rosiglitazone in Treating Patients With Liposarcoma

NCT ID: NCT00004180

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2015-05-31

Brief 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.

Detailed 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.

Conditions

Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Well-differentiated liposarcoma

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

Group Type: EXPERIMENTAL

rosiglitazone maleate

Intervention Type: DRUG

De-differentiated liposarcoma

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

Group Type: EXPERIMENTAL

rosiglitazone maleate

Intervention Type: DRUG

Myxoid/ round-cell liposarcoma

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

Group Type: EXPERIMENTAL

rosiglitazone maleate

Intervention Type: DRUG

Pleomorphic liposarcoma

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

Group Type: EXPERIMENTAL

rosiglitazone maleate

Intervention Type: DRUG

Interventions

rosiglitazone maleate

Intervention Type: DRUG

Other Intervention Names

Rosiglitazone

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

George Demetri, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George D. Demetri, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DFCI-99083

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G99-1629

Identifier Type: -

Identifier Source: secondary_id

CDR0000067406

Identifier Type: -

Identifier Source: org_study_id