A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia|
- Response rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.
Patients will take three 50 mg tablets of perifosine qhs daily (for 28 days cycles) with food. Patients may need anti-emetics and/or anti-diarrheas. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Patients with progressive disease or who refuse further therapy will be discontinued from the protocol. Dose modifications for toxicity will be performed.
Standard criteria for evaluation of response in WM recommended by the Second International WM Workshop will be used in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398710
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Irene M Ghobrial, MD||Dana-Farber Cancer Institute|