Brostallicin Clinical Trial for Myxoid Liposarcoma

NCT00633165 | Unknown Phase 2

• 1 other identifier: SMI-BRS-202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myxoid Liposarcoma

Keywords

sarcoma; myxoid liposarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• To determine progression free survival.

  Tumor measurements after every 2 cycles and there is no limit to the number of cycles.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• \> 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

Sponsors & Collaborators

• Systems Medicine LLC: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Related Links

• Study Sponsor

MeSH Terms

Conditions

Liposarcoma, Myxoid; Sarcoma

Interventions

brostallicin

Condition Hierarchy (Ancestors)

Liposarcoma; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jack Singer, M.D.

  CTI BioPharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: June 1, 2010
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

US (1)