A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT00398710|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : March 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Waldenström's Macroglobulinemia||Drug: Perifosine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia|
|Study Start Date :||October 2006|
|Primary Completion Date :||August 2011|
|Study Completion Date :||October 2011|
- Response rate [ Time Frame: Every 4 weeks ]
- Toxicities [ Time Frame: Every 4 weeks ]
- Time to progression [ Time Frame: Every 4 weeks ]
- Progression free survival [ Time Frame: Every 4 weeks ]
- Duration of response [ Time Frame: Every 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398710
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Irene M Ghobrial, MD||Dana-Farber Cancer Institute|