A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00398710|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : March 15, 2018
|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|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||October 2011|
Patients will receive perifosine orally at 150 mg daily after food for 28-d cycles.
150 mg daily (100 mg daily in case of dose reduction)
- Response rate [ Time Frame: Every 4 weeks ]Response will include complete remission, partial remission (PR), and minimal response (MR) using serum protein electrophoresis. Response will also be assessed by IgM using nephelometry.
- Safety [ Time Frame: Every 4 weeks ]Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 3.0) from the first dose until 30 d after the last dose of perifosine.
- Time to progression [ Time Frame: Every 4 weeks ]This will be calculated using Kaplan-Meier methodology.
- Progression free survival [ Time Frame: Every 4 weeks ]This will be calculated using Kaplan-Meier methodology.
- Duration of response [ Time Frame: Every 4 weeks ]This will be reported among responding patients.
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|