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Rosiglitazone in Treating Patients With Liposarcoma

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ClinicalTrials.gov Identifier: NCT00004180
Recruitment Status : Completed
First Posted : May 9, 2003
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Demetri, M.D., Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 21, 2000
First Posted Date  ICMJE May 9, 2003
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE October 1999
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00004180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rosiglitazone in Treating Patients With Liposarcoma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: rosiglitazone maleate
Other Name: Rosiglitazone
Study Arms  ICMJE
  • Experimental: Well-differentiated liposarcoma
    Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
    Intervention: Drug: rosiglitazone maleate
  • Experimental: De-differentiated liposarcoma
    Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
    Intervention: Drug: rosiglitazone maleate
  • Experimental: Myxoid/ round-cell liposarcoma
    Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
    Intervention: Drug: rosiglitazone maleate
  • Experimental: Pleomorphic liposarcoma
    Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth.
    Intervention: Drug: rosiglitazone maleate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2017)
32
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004180
Other Study ID Numbers  ICMJE CDR0000067406
P30CA006516 ( U.S. NIH Grant/Contract )
DFCI-99083 ( Other Identifier: Dana-Farber Cancer Institute )
NCI-G99-1629
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party George Demetri, M.D., Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP