Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of auranofin plus sirolimus (Cohort I). II. To determine the confirmed response rate of auranofin plus sirolimus (Cohort II). SECONDARY OBJECTIVES: I. To describe the adverse event and toxicity profiles associated with this treatment combination. II. To evaluate response, time to progression, progression-free survival (PFS), overall survival (OS), and time to treatment failure in patients treated with this treatment combination. TERTIARY OBJECTIVES: I. To evaluate tumor biomarkers of protein kinase C (PKC) and mammalian target of rapamycin (mTOR) signaling activity as predictors of clinical outcome (i.e. response, PFS, OS) for patients receiving auranofin/sirolimus therapy. II. To evaluate the use of surrogate biomarkers of PKC and mTOR inhibition in peripheral blood lymphocytes (PBLs) as predictors of clinical outcome (i.e. response, PFS, OS) for patients receiving auranofin/sirolimus therapy. OUTLINE: This is a cohort I, dose-escalation study followed by a cohort II study. Patients receive auranofin orally (PO) once daily (QD) and sirolimus PO 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 3-6 months for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
