Trial of Two Schedules of Perifosine for Patients With Solid Tumors or Lymphomas
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IIA Trial of Two Schedules of Perifosine|
- Overall Response Rate (PR + CR) [ Time Frame: Evaluated every 12 weeks ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: From date of randomization ] [ Designated as safety issue: No ]
- Safety [ Time Frame: Every treatment cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||September 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Daily Dose Perifosine
Drug: Perifosine Daily Dose
Daily Dose Perifosine
Experimental: Weekly Dose Perifosine
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.