A 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
Title A 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
Contact AS
Principal Investigator Roberto Pili, MD
Study Number 145208
PhaseI/II
Summary
Phase I of this study will evaluate the safety and tolerability of high dose interleukin 2 (aldesleukin) in combination with entinostat in patients with metastatic RCC.
Phase II will monitor toxicity and estimate the efficacy of high dose aldesleukin combined with entinostat in patients with metastic RCC.
Eligibility
- Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or unresectable. The histology must be clear cell carinoma or predominant clear cell carcinoma
- No prior systemic therapies for RCC are allowed. Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been radiated.
- Must have measurable or evaluable disease.
- Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias or unstable angina
- CNS: No history of cerebrovascular accident, transient ischemic attacks. Patients will have a head CT/MRI within 28 days prior to treatment initiation. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study. Patients with previously excised/gamma knifed solitary or oligometastases and controlled disease are eligible.
