SarcomaPhase 2NCT00004180
Rosiglitazone in Treating Patients With Liposarcoma
A Phase 2 study testing rosiglitazone maleate in people with Sarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- rosiglitazone maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- rosiglitazone maleate
- Keywords
- adult liposarcoma, recurrent adult soft tissue sarcoma
- Medical subject headings
- Sarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazone maleateDrug
Also called Rosiglitazone
| Study group | Role | What they receive |
|---|---|---|
| Well-differentiated liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. Receives: Drug: rosiglitazone maleate |
| De-differentiated liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. Receives: Drug: rosiglitazone maleate |
| Myxoid/ round-cell liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. Receives: Drug: rosiglitazone maleate |
| Pleomorphic liposarcoma | Experimental | Participants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. Receives: Drug: rosiglitazone maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2003 (estimated)
- Study startOct 1999
- Primary completionMar 2006
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, George Demetri, MD, Dana-Farber Cancer Institute
- Investigators
- George D. Demetri, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004180
- Sponsor's protocol ID
- CDR0000067406
- Other IDs
- P30CA006516, DFCI-99083, NCI-G99-1629
- Status last verified
- Jun 2023
- First submitted
- 21 Jan 2000
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00004180
- Acronym / sponsor ID
- CDR0000067406
- Conditions
- Sarcoma
- Keywords
- adult liposarcoma, recurrent adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Mar 2006 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Well-differentiated liposarcoma | Experimental | Drug: rosiglitazone maleateParticipants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
| De-differentiated liposarcoma | Experimental | Drug: rosiglitazone maleateParticipants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
| Myxoid/ round-cell liposarcoma | Experimental | Drug: rosiglitazone maleateParticipants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
| Pleomorphic liposarcoma | Experimental | Drug: rosiglitazone maleateParticipants in this arm receive 4 mg of study drug (rosiglitazone maleate) twice daily by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone maleateAlso: Rosiglitazone | Drug | De-differentiated liposarcoma, Myxoid/ round-cell liposarcoma, Pleomorphic liposarcoma, Well-differentiated liposarcoma |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George D. Demetri, MD study chair
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosiglitazone maleate in people with Sarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of biological response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023; AzTrials last refreshed its copy on 2 Nov 2026.