This study collects tumor samples to see if the presence of an enzyme called TOPO2A can help predict how well patients with soft tissue sarcoma respond to standard of care treatment with doxorubicin or Doxil. Enzymes are biological molecules (proteins) that help complex reactions happen in the body. Patients with a greater amount of TOPO2A in a sample of their tissue may respond better to treatment with one of the two standard of care drugs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04055753.
PRIMARY OBJECTIVE:
I. Determine the utility of TOPO2A expression as a biomarker of sensitivity to doxorubicin in soft tissue sarcoma (STS).
SECONDARY OBJECTIVES:
I. Determine the association between TOPO2A expression in STS and survival.
II. Determine the association of TOPO2A with clinical parameters in STS.
OUTLINE:
Patients undergo collection of tissue sample prior to initiation of therapy. Patients then receive standard of care doxorubicin intravenously (IV) over 5-15 minutes or continuously over 48-96 hours on day 1 or pegylated liposomal doxorubicin hydrochloride (Doxil) IV over 1 hour on day 1. Cycles with doxorubicin repeat every 21 days and cycles with Doxil repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up every 3 months during year 1, every 6 months during year 2, then annually thereafter.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorMargaret von Mehren