LBH589 Treatment for Refractory Clear Cell Renal Carcinoma

Inclusion Criteria

• •Histologically documented metastatic or locally unresectable clear cell renal carcinoma. In patients with mixed histologies, the clear cell component must comprise \> 75% of the cancer.
• •Documented disease progression or intolerance while receiving treatment with: a) sunitinib, sorafenib, or both, and b) temsirolimus.
• •Maximum of 4 prior systemic regimens allowed and may include other targeted agents, immunotherapy and chemotherapy.
• •Measurable disease by RECIST criteria.
• •ECOG PS 0 or 1.
• •Laboratory values as follows: ANC \>= 1500/μL, Hgb \>= 9 g/dL, Platelets \>= 100,000/uL, AST/SGOT and ALT/SGPT \<= 2.5 x ULN or \<= 5.0 x ULN in patients with liver metastases, Creatinine \<= 2.0 mg/dL Or Calculated Creatinine Clearance \>= 50 ml/min, Albumin \>= 3 g/dL, Potassium \>= lower limit normal (LLN),Phosphorous \>= LLN, Calcium \>= LLN, Magnesium \> LLN
• •Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment.
• •Life expectancy \> 12 weeks.
• •Accessible for treatment and follow-up.
• •All patients must be able to understand the nature of the study and give written informed consent prior to study entry.
• •Active meningeal metastases.
• •Known diagnosis of human immunodeficiency virus (HIV) infection.
• •Unresolved diarrhea \> CTCAE grade 1.
• •Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
• •Chemotherapy, investigational drug therapy, major surgery \< 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy.
• •Patient is \< 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
• •Concomitant use of any anti-cancer therapy or radiation therapy.
• •Pregnant or breast feeding or female of reproductive potential not using 2 effective methods of birth control.
• •Male patients whose sexual partners are women of childbearing potential not using effective birth control.
• •Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease.
• •Other concurrent severe, uncontrolled infection or intercurrent illness
• •Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.