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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brostallicin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin. | Tumor measurements after every 2 cycles and there is no limit to the number of cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population. | Tumor measurements after every 2 cycles and there is no limit to the number of cycles. | |
| Duration of response | Tumor measurements after every 2 cycles and there is no limit to the number of cycles. |
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Inclusion Criteria:
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).
Life expectancy of at least 3 months.
Acceptable liver function:
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:
Exclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jack Singer, M.D. | CTI BioPharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
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| Label | URL |
|---|---|
| Study Sponsor | View source |
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| ID | Term |
|---|---|
| D018208 | Liposarcoma, Myxoid |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C455279 | brostallicin |
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| To determine progression free survival. | Tumor measurements after every 2 cycles and there is no limit to the number of cycles. |
| D009369 | Neoplasms |