Rosiglitazone in Treating Patients With Liposarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Demetri, M.D., Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004180
First received: January 21, 2000
Last updated: February 4, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: rosiglitazone maleate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evidence of biological response [ Designated as safety issue: No ]
    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.


Enrollment: 33
Study Start Date: October 1999
Estimated Study Completion Date: July 2016
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Well-differentiated liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: 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 Name: 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 Name: Rosiglitazone
Experimental: Pleomorphic liposarcoma
Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
Drug: rosiglitazone maleate
Other Name: Rosiglitazone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004180

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: George Demetri, M.D., Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00004180     History of Changes
Other Study ID Numbers: CDR0000067406  P30CA006516  DFCI-99083  NCI-G99-1629 
Study First Received: January 21, 2000
Last Updated: February 4, 2016
Health Authority: United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:
adult liposarcoma
recurrent adult soft tissue sarcoma

Additional relevant MeSH terms:
Sarcoma
Liposarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue
Rosiglitazone
Maleic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016