Completed

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

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What is being tested

rosiglitazone maleate

+ rosiglitazone maleate

+ rosiglitazone maleate

Drug
Who is being recruted

Neoplasms+3

+ Neoplasms by Histologic Type

+ Neoplasms, Connective and Soft Tissue

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: June 26, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004180
Principal SponsorDana-Farber Cancer Institute
Last updated: June 26, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

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

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective and Soft TissueNeoplasms, Adipose TissueLiposarcomaSarcoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Dana-Farber Cancer Institute

Boston, United StatesOpen Dana-Farber Cancer Institute in Google Maps
CompletedOne Study Center