Brostallicin Clinical Trial for Myxoid Liposarcoma

Myxoid Liposarcoma Clinical Trial

— SMI-BRS-202  

Official title:

A Phase II, Multicenter Study to Explore the Efficacy and Safety of Brostallicin in Patients With Myxoid Liposarcoma With (12:16) Translocation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00633165
• Other study ID #: SMI-BRS-202
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: February 24, 2010
• Start date: August 2007
• Est. completion date: June 2010

Study information

• Verified date: February 2010
• Source: Systems Medicine LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The primary objective of this study is to determine the response rate following Brostallicin administration.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has provided informed consent.

2. Histologically confirmed myxoid liposarcoma.

3. Patients with metastatic and/or unresectable myxoid liposarcoma that is progressive and standard curative measures do not exist or are no longer effective.

4. Patient has measurable tumor on CT, spiral CT, or MRI scan that meet RECIST criteria.

5. Age =18 years

6. Karnofsky performance status (KPS) = 70% (see Appendix III).

7. Life expectancy of at least 3 months.

8. 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).

9. 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.

10. 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.

Exclusion Criteria:

1. 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).

2. Patients heavily pretreated with chemotherapy and radiation, defined as follows:

• = 12 cycles of an alkylating agent-containing regimen, or

• > 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.

3. Known hypersensitivity to any study drug component.

4. Uncontrolled brain metastases in the judgement of the Investigator.

5. 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).

6. 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.

7. Not recovered from acute toxicity of all previous therapy prior to enrollment.

8. 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.

9. 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.

10. Any active uncontrolled infection including AIDS, hepatitis B or C.

11. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow up schedule.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liposarcoma
• Liposarcoma, Myxoid
• Myxoid Liposarcoma

Intervention

Drug:
• Brostallicin
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.

Locations

Country	Name	City	State
United States	Sarcoma Oncology Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Systems Medicine LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes
Secondary	Duration of response		Tumor measurements after every 2 cycles and there is no limit to the number of cycles.	No
Secondary	To determine progression free survival.		Tumor measurements after every 2 cycles and there is no limit to the number of cycles.	No