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Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

2019-08-19 19:46:45 | BioPortfolio

Summary

The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study.

Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.

Study Design

Conditions

Soft Tissue Sarcoma

Intervention

Doxil, Doxorubicin

Location

Fox Chase Cancer Center
Philadelphia
Pennsylvania
United States
19111

Status

Recruiting

Source

Fox Chase Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-19T19:46:45-0400

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Medical and Biotech [MESH] Definitions

Injuries of tissue other than bone. The concept is usually general and does not customarily refer to internal organs or viscera. It is meaningful with reference to regions or organs where soft tissue (muscle, fat, skin) should be differentiated from bones or bone tissue, as "soft tissue injuries of the hand".

The assessment, treatment, and management of soft tissue injury or dysfunction. Therapy is designed to reduce tension and irritation in affected tissues and may include MASSAGE; muscle stretching, or direct pressure on muscles, connective tissue, and TRIGGER POINTS.

Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)

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