This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are: * To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor * To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this study are: 1. To measure clinical benefit defined as an objective tumor response using RESIST or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor 2. To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor. Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression. Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Perifosine 100 mg PO Perifosine is supplied as a film-coated tablet containing 50 mg of active ingredient. Treatment will be administered on an outpatient basis in 28-day cycles. The patient dose for daily administration will be 100 mg qhs daily with food.
Investigative Site
Louisville, Kentucky, United States
Investigative Site
Morristown, New Jersey, United States
Investigative Site
Armonk, New York, United States
Objective tumor response using RESIST OR progression-free survival
Clinical benefit, defined as either an objective response by RECIST or PFS \>12 weeks, is a primary endpoint of the study. The clinical benefit rate together with its two-sided exact binomial 95% confidence interval will be reported.
Time frame: 12 weeks
Evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney
Safety endpoints include: incidence of adverse events, serious adverse events, change in vital signs and change in laboratory results (hematology, blood chemistry, urinalysis).
Time frame: 12 weeks
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