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Clinical Trial Summary

This phase I trial studies the side effects and best dose of sirolimus and gold sodium thiomalate when given together in treating patients with advanced squamous non-small cell lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of ATM (gold sodium thiomalate) plus sirolimus. SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II. To preliminarily evaluate the response rate, time to progression, progression-free survival and overall survival of patients treated with this treatment combination. TERTIARY OBJECTIVES: I. To evaluate tumor biomarkers of protein kinase C (PKCĪ¹) and mammalian Target Of Rapamycin (mTOR) signaling activity as predictors of response to ATM/sirolimus therapy. II. To evaluate the use of surrogate biomarkers of PKCĪ¹ and mTOR inhibition in peripheral blood lymphocytes (PBLs) to monitor response to ATM/sirolimus therapy. OUTLINE: This is a dose-escalation study. Patients receive sirolimus orally (PO) once daily (QD) on days 1-28 and gold sodium thiomalate intramuscularly (IM) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01383668
Study type Interventional
Source Mayo Clinic
Contact
Status Withdrawn
Phase Phase 1
Start date June 2011
Completion date February 8, 2013

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