Rosiglitazone in Treating Patients With Liposarcoma

June 22, 2023 updated by: George Demetri, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Well-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Names:
  • Rosiglitazone
Experimental: De-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Names:
  • Rosiglitazone
Experimental: Myxoid/ round-cell liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Names:
  • Rosiglitazone
Experimental: Pleomorphic liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Names:
  • Rosiglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: George D. Demetri, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

May 8, 2003

First Posted (Estimated)

May 9, 2003

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067406
  • P30CA006516 (U.S. NIH Grant/Contract)
  • DFCI-99083 (Other Identifier: Dana-Farber Cancer Institute)
  • NCI-G99-1629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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