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Assessment of TOPO2A as a Biomarker for Sensitivity to Doxorubicin or Doxil in Patients with Soft Tissue Sarcoma

Trial Status: Active

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.

Inclusion Criteria

  • Patients must consent to providing tumor tissue prior to initiation of therapy if sufficient archival tissue is not available. The use of archival tissue is permitted. If a biopsy is required, the treating physician should ensure that this can be done safely
  • Patients with STS will be eligible for the trial if their next planned chemotherapy will include single agent doxorubicin or Doxil. Patients who will be receiving concomitant therapy with olaratumab will be allowed to participate
  • Sarcoma subtypes of angiosarcoma, epithelioid sarcoma, leiomyosarcoma, fibrosarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic rhabdomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma (excluding well-differentiated) and malignant peripheral nerve sheath tumor will be included. These are subtypes for which a targeted therapy is not standard of care. All other subtypes will be included on a case by case basis as determined by the principal investigator
  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field)

Exclusion Criteria

  • Patients may not be receiving any other investigational agents, chemotherapy, radiation therapy or hormonal therapy (i.e. aromatase inhibitors for leiomyosarcoma)
  • Any concomitant medical issue that in the opinion of the treating physician would confound survival from sarcoma (e.g. other active cancer, symptomatic brain metastases, cardiac conditions)

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Margaret von Mehren
Phone: 215-728-2460

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 Phase Phase NA

Trial Type Diagnostic

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Margaret von Mehren

  • Primary ID 16-1015
  • Secondary IDs NCI-2020-01532
  • Clinicaltrials.gov ID NCT04055753