Phase I/II study of high dose interleukin 2, aldesleukin, in combination with the histone deacetylase inhibitor entinostat in patients with metastatic renal cell carcinoma.
To evaluate the safety and tolerability of high dose Interleukin 2 (aldesleukin) in combination with entinostat in patients with metastatic renal cell carcinoma.
Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically resectable. The histology must be clear cell carcinoma or predominant clear cell carcinoma. No prior therapies for renal cell cancer are allowed. Patients must have an accessable tumor for biopsy. Good perfomance status. Normal organ function and bone marrow function. Must have adequate pulmonary function, and no evidence of congestive heart failure, coronary artery disease, or MI within 6 months. No brain mets, except those with previously excised/gamma knifed solitary or oligometastases are eligible. No active infections allowed. Pregnant women are excluded as are HIV patients. Need left ventricular ejection function greater than 45%.
The patient will receive oral Entinostat (1-2 hours prior to IL2)given every 2 weeks starting on day -14 continuously. The Entinostat will be dosed based on the cohort. The IL2 dosing will consist of 2 courses of IL2 600,000 units/kg administered IV every 8 hours on days 1-5 and 15-19. The patient will have tumor response assessment at week 11. In the event of clinical benefit (stable disease or shrinkage of tumor) patients will receive a second cycle of therapy.
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