Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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 a need to identify new therapeutic agents for WM patients both in the upfront and relapsed/refractory setting. The purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory WM.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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