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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

George D. Demetri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067406

NCT ID:

NCT00004180

Start Date:

October 1999

Completion Date:

December 2013

Related Keywords:

  • Sarcoma
  • adult liposarcoma
  • recurrent adult soft tissue sarcoma
  • Liposarcoma
  • Sarcoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115