Study of Everolimus and Low-dose Cyclophosphamide in Patients With Metastatic Renal Cell Cancer
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
In the present phase 1-2 study the investigators aim to determine whether depletion of Tregs
using metronomic cyclophosphamide can enhance the antitumor efficacy of everolimus in
patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase
inhibitor containing treatment regimen. In the phase 1 part of the study the investigators
will determine the optimal CD4+CD25+ regulatory T cell-depleting dose and schedule of
metronomic oral cyclophosphamide when given in combination with a fixed dose (10 mg daily) of
everolimus. In the phase 2 part of the study the investigators will subsequently evaluate
whether the number of patients who are cancer progression free at 4 months can be increased
from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in
the phase 1 part) to everolimus. In addition to efficacy, the investigators will evaluate
treatment toxicity to determine whether this combination strategy is feasible and safe.