This is a study of the drug perifosine for patients who have no standard treatment options. This study is designed to identify which cancer types respond to perifosine, and determine which regimen of perifosine is most effective in each one. Patients with either solid tumors or with lymphomas for whom this protocol represents reasonable or optimal treatment will be randomized to receive either perifosine 100 mg daily or 900 mg weekly until disease progression. Based on currently available data it is anticipated that these doses should be easily tolerated by most patients.
This is an exploratory phase IIA trial with unique elements of design and patient selection with an aim to: * Identify responsive tumor types that were not predicted from preclinical and Phase I studies, * Determine if tumors are more likely to stabilize than shrink, and * Identify a dose with almost no toxicity. * To determine whether response (or stabilization) can be observed on either a daily or weekly schedule, or both. Since the efficacy goal of the study is to look for any evidence of activity with perifosine, the daily and weekly arms will be combined when assessing response. * Response to therapy will be based on either tumor regression (objective response, partial or complete) OR stabilization of disease. It is not anticipated that this study will provide "proof of principle" regarding the use of perifosine or serve as a pivotal trial for regulatory purposes. Information obtained from this study will be used to design additional trials that will be more definitive in nature.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
558
Perifosine 50 mg tablets
Overall Response Rate (PR + CR)
To determine for each disease category the proportion of patients treated with perifosine who experience a favorable outcome, defined as a complete or partial response; a 50% increase in progression-free survival compared to patient's latest treatment regimen for metastatic disease, or stabilization of disease.
Time frame: Evaluated every 12 weeks
To Show that doses will be each sufficiently and tolerated
To show that daily 50 mg daily and 50 mg twice-daily doses are each sufficiently well tolerated to ensure good compliance in future studies of these two regimens
Time frame: From date of randomization
To obtain plasma levels
To obtain perifosine plasma levels in a subset of patients to evaluate variability in drug uptake between patients, and to correlate plasma levels with outcomes to insure good compliance in future studies of these two regimens
Time frame: Every treatment cycle
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