Rosiglitazone in Treating Patients With Liposarcoma

NCT00004180 | Completed Phase 2

• 4 other identifiers: CDR0000067406P30CA006516DFCI-99083NCI-G99-1629
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

adult liposarcoma; recurrent adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Well-differentiated liposarcoma

EXPERIMENTAL

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

Drug: rosiglitazone maleate

De-differentiated liposarcoma

EXPERIMENTAL

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

Drug: rosiglitazone maleate

Myxoid/ round-cell liposarcoma

EXPERIMENTAL

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

Drug: rosiglitazone maleate

Pleomorphic liposarcoma

EXPERIMENTAL

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

Drug: rosiglitazone maleate

Interventions

rosiglitazone maleate DRUG

Also known as: Rosiglitazone

De-differentiated liposarcoma; Myxoid/ round-cell liposarcoma; Pleomorphic liposarcoma; Well-differentiated liposarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sarcoma; Liposarcoma

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• George D. Demetri, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: May 9, 2003
• Study Start: October 1, 1999
• Primary Completion: March 1, 2006
• Study Completion: May 1, 2015
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)