Ph II Study of Perifosine for Patients With Carcinoma of the Kidney

Inclusion Criteria

• •Patients with confirmed metastatic RCC
• •Patients must have documented progression on treatment with sunitinib or sorafenib. Prior therapy with bevacizumab and/or cytokines (i.e., IL-2, interferon) is permitted. Prior vaccine therapy in the adjuvant setting is also permitted. Patients can have failed therapy with ONE prior mTOR inhibitor.
• •Patients must have at least one measurable lesion on computer tomography (CT) Scan or magnetic resonance imaging (MRI) using Modified RECIST criteria.
• •Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:
• •* ANC \>= 1.5 x 109/L
• •* Platelets \>= 75,000/ mm3
• •* HCT \>= 28% (with or without growth factor support)
• •* Creatinine \<= 3.0 mg/dl
• •* Total bilirubin \<= 1.5 x upper limit of normal
• •* Transaminase \<= 2.5 x upper limit of normal
• •ECOG performance status of 0 or 1
• •Patients with CNS metastases must be clinically stable for at least 2 months following treatment with radiation therapy, surgery, or both; and be off corticosteroids and anti-seizure medication.
• •Patients with a life expectancy ≥6 months
• •Age ≥18 years old
• •Patients who give a written informed consent obtained according to local guidelines
• •Women of childbearing potential must have had a negative serum or urine pregnancy test 72 hours prior to the administration of the first study treatment.