Clinical trial NCT00004180: Rosiglitazone in Treating Patients With Liposarcoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Keywords: adult liposarcoma
recurrent adult soft tissue sarcoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evidence of biological response
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: George D. Demetri, MD
role: STUDY_CHAIR
References: