Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Rosiglitazone in Treating Patients With Liposarcoma

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.

Eligibility: 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

Relevance to patient case: not relevant