Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma
Targeted therapies are associated with (acquired) resistance after a median of 5-11 months
of treatment, resulting in disease progression, while almost no tumors are intrinsically
resistant in the first line setting. The investigators recently published that tumor cell
resistance to sunitinib may be directly related to lysosomal sequestration of sunitinib.
This resistance mechanism was shown to be transient, since a drug-free culture period could
normalize the lysosomal storage capacity for sunitinib and resulted in recovery of drug
sensitivity.
In two reports it has been suggested that patients with metastatic Renal Cell Carcinoma who
responded to sunitinib in the first-line setting may benefit from rechallenge with sunitinib
after failure of second-line treatment. However, these data are retrospective. A prospective
trial to investigate a rechallenge with sunitinib is needed to determine whether this
strategy is of benefit for patients with mRCC with prior clinical benefit to sunitinib but
who stopped treatment because of overt clinical resistance.
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