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

Systems Medicine LLC1 site in 1 country24 target enrollmentAugust 2007

ConditionsMyxoid Liposarcoma

DrugsBrostallicin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Myxoid Liposarcoma
Sponsor: Systems Medicine LLC
Enrollment: 24
Locations: 1
Primary Endpoint: To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin.
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

June 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Systems Medicine LLC

Eligibility Criteria

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:
•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.)