This phase I/II trial studies the side effects and the best dose of prasterone and to see how well it works in treating patients with synovial sarcoma that has spread from the primary site to other places in the body or cannot be removed by surgery. Prasterone may kill tumor cells by blocking an enzyme needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02683148.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of prasterone (dehydroepiandrosterone [DHEA]) in the treatment of synovial sarcoma. (Phase I)
II. To determine the progression free rate (complete response [CR] + partial response [PR] + stable disease [SD]) of patients with synovial sarcoma receiving the MTD of DHEA. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the rate of progression-free survival (PFS) of patients with synovial sarcoma receiving DHEA in the Phase II portion of the trial.
II. To evaluate the toxicity of DHEA in the treatment of synovial sarcoma.
TERTIARY OBJECTIVES:
I. To evaluate malic enzyme 1 (ME1) expression of specimens collected from patients with synovial sarcoma being treated with DHEA.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive prasterone orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 5 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorBrian Andrew Van Tine