Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

ABSTRACT:

Background

For patients with metastatic renal cell cancer (mRCC) who progressed on vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor therapy, the orally administered mammalian target of rapamycin (mTOR) inhibitor everolimus has been shown to prolong progression free survival. Intriguingly, inhibition of mTOR also promotes expansion of immunosuppressive regulatory T cells (Tregs) that can inhibit anti-tumor immune responses in a clinically relevant way in various tumor types including RCC. This study intends to investigate whether the antitumor efficacy of everolimus can be increased by preventing the detrimental everolimus induced expansion of Tregs using a metronomic schedule of cyclophosphamide.

Methods/design

This phase I-II trial is a national

SUBMITTER: Huijts CM 

PROVIDER: S-EPMC3305518 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature