Status:
COMPLETED
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with limited therapeutic options and notably absent FDA approved therapy with any WM indication. Therefore, there is ...
Detailed Description
Perifosine is a drug that in particular inhibits Akt thought to be important for initiation and progression of malignancies, specifically in lymphomas. In laboratory experiments of WM and lymphoma cel...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Must have received prior therapy for their WM and have relapsed or refractory WM. Any number of prior therapies is acceptable
- Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the ULN and over 10% of lymphoplasmacytic cells in bone marrow
- ECOG Performance Status 0,1, or 2
- Laboratory values as described in the protocol
- Life expectancy of greater than 12 weeks
Exclusion
- Uncontrolled infection
- Other active malignancies
- CNS involvement
- Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
- Pregnant or nursing women
- Known to be HIV positive
- Radiation therapy less than 2 weeks prior to registration
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00422656
Start Date
September 1 2006
End Date
November 1 2012
Last Update
December 26 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115