Primary Outcome Measures:
- Complete remission [ Time Frame: Evaluated every 12 weeks ]
- Partial remission [ Time Frame: Evaluated every 12 weeks ]
- Increase in the time to progression [ Time Frame: Evaluated every 12 weeks ]
- Toxicities [ Time Frame: Every treatment cycle ]
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.