Myxoid LiposarcomaPhase 2SMI-BRS-202NCT00633165
Brostallicin Clinical Trial for Myxoid Liposarcoma
A Phase 2 study testing Brostallicin in people with Myxoid Liposarcoma, run by Systems Medicine LLC at 1 site in United States.
Trial summary
This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myxoid Liposarcoma
- What is being tested?
- Brostallicin
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2010
- 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
Who may be able to join
- Patient has provided informed consent.
- Histologically confirmed myxoid liposarcoma.
- Patients with metastatic and/or unresectable myxoid liposarcoma that is progressive and standard curative measures do not exist or are no longer effective.
- Patient has measurable tumor on CT, spiral CT, or MRI scan that meet RECIST criteria.
- Age ≥18 years
- Karnofsky performance status (KPS) ≥ 70% (see Appendix III).
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- Life expectancy of at least 3 months.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 2.5 times ULN (if liver metastases are present, then ≤ 5 × ULN is allowed).
- Acceptable renal function: For all patients serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm(3) (1.5 ×10(9)/L)
- Platelet count ≥ 100,000 platelet/mm(3) (100 ×10(9)/L)
- Hemoglobin ≥ 9 g/dL.
Who cannot join
- Patient received any of the following within the specified time period prior to initiation of treatment in this study:
- Chemotherapy, major surgery, significant traumatic injury, or irradiation, whether conventional or investigational within 28 days
- Mitomycin-C or nitrosurea within 42 days.
- ET-743 at any time (Stage 1 only).
- Patients heavily pretreated with chemotherapy and radiation, defined as follows:
- ≥ 12 cycles of an alkylating agent-containing regimen, or
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- > 2 cycles carboplatin, or
- > 2 cycles mitomycin C, or
- irradiation to 25% of bone marrow-containing areas, or
- high-dose chemotherapy requiring hematopoietic stem-cell reinfusion.
- Known hypersensitivity to any study drug component.
- Uncontrolled brain metastases in the judgement of the Investigator.
- Abnormal cardiac or cardiovascular function, or serious cardiac illness or medical condition in the previous 6 months including, but not confined to:
- New York Heart Association (NYHA) grade 2 or higher congestive heart failure (CHF) or who has had angioplasty or placement of coronary stents within the previous 6 months
- Myocardial infarction within the past 6 months
- High-risk uncontrolled arrhythmias
- Angina pectoris that requires antianginal medication
- Has clinically significant valvular heart disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension (e.g., blood pressure: systolic >180 mm Hg or diastolic >100 mm Hg).
- Pregnant or lactating females. All patients (males and females) who are fertile must agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
- Not recovered from acute toxicity of all previous therapy prior to enrollment.
- History of prior malignancies within 3 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.
- Any evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining informed consent.
- Any active uncontrolled infection including AIDS, hepatitis B or C.
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow up schedule.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: A Phase II, Multicenter Study to Explore the Efficacy and Safety of Brostallicin in Patients With Myxoid Liposarcoma With (12:16) Translocation
This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. The primary objective of this study is to determine the response rate following Brostallicin administration.
- Conditions
- Myxoid Liposarcoma
- Being tested
- Brostallicin
- Keywords
- sarcoma, myxoid liposarcoma
- Medical subject headings
- Liposarcoma, Myxoid, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrostallicinDrug
Patients will receive Brostallicin administered intravenously (IV) over 10 minutes at a dose of 10 mg/m2 on day one of a 21-day cycle. Safety and efficacy will be closely monitored and assessed.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin.
Measured: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
Secondary outcomes (3)
To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population.
Measured: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
Duration of response
Measured: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
To determine progression free survival.
Measured: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myxoid LiposarcomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Systems Medicine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jack Singer, M.D., Study chair, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633165
- Sponsor's protocol ID
- SMI-BRS-202
- Acronym
- SMI-BRS-202
- Status last verified
- Feb 2010
- First submitted
- 3 Mar 2008
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter Study to Explore the Efficacy and Safety of Brostallicin in Patients With Myxoid Liposarcoma With (12:16) Translocation
- ClinicalTrials.gov ID
- NCT00633165
- Acronym / sponsor ID
- SMI-BRS-202 / SMI-BRS-202
- Conditions
- Myxoid Liposarcoma
- Keywords
- sarcoma, myxoid liposarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Systems Medicine LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Mar 2008 (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.
This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. The primary objective of this study is to determine the response rate following Brostallicin administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient has provided informed consent.
- Histologically confirmed myxoid liposarcoma.
- Patients with metastatic and/or unresectable myxoid liposarcoma that is progressive and standard curative measures do not exist or are no longer effective.
- Patient has measurable tumor on CT, spiral CT, or MRI scan that meet RECIST criteria.
- Age ≥18 years
Key exclusion criteria (26 listed)
- Patient received any of the following within the specified time period prior to initiation of treatment in this study:
- Patients heavily pretreated with chemotherapy and radiation, defined as follows:
- Known hypersensitivity to any study drug component.
- Uncontrolled brain metastases in the judgement of the Investigator.
- Abnormal cardiac or cardiovascular function, or serious cardiac illness or medical condition in the previous 6 months including, but not confined to:
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 |
|---|---|---|
| BrostallicinPatients will receive Brostallicin administered intravenously (IV) over 10 minutes at a dose of 10 mg/m2 on day one of a 21-day cycle. Safety and efficacy will be closely monitored and assessed. | Drug | – |
Primary outcome
To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin.
Time frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
3 secondary outcomes
To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population.
Time frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
Duration of response
Time frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
To determine progression free survival.
Time frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Study SponsorLink provided by the sponsor.
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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.
Jack Singer, M.D. study chair
CTI BioPharma
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 Brostallicin in people with Myxoid Liposarcoma, run by Systems Medicine LLC 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?
The sponsor lists 15 inclusion and 26 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 26 Feb 2010. 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?
Results are not available in the source record.
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?
To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin. (time frame: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.). 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 Feb 2010.