Status:
COMPLETED
A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
Lead Sponsor:
AEterna Zentaris
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Waldenström's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 st...
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- Age \>= 18 years.
- 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 (IgM) paraprotein with a minimum IgM level of \> 2 times the upper limit of each institution's normal value is required and over 10% of lymphoplasmacytic cells in the bone marrow.
- ECOG Performance Status (PS) 0, 1, or 2.
- The following laboratory values obtained 14 days prior to registration
- ANC \>= 1 x109/L
- PLT \>= 75 x109/L
- Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.)
- AST \<= 3 x upper limit of normal (ULN)
- Creatinine \<= 2 x ULN
- Ability to provide informed consent.
- Life expectancy \>= 12 weeks.
Exclusion
- Uncontrolled infection.
- Other active malignancies.
- CNS involvement.
- Cytotoxic chemotherapy ≤ 3 weeks, or biologic therapy ≤ 2 weeks, or corticosteroids ≤ 2 weeks, prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than WM such as auto-immune diseases. Plasmapheresis is not considered as an active therapy and can be used at the physician's discretion.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device (IUD), or abstinence, etc.)
- Known to be HIV positive.
- Radiation therapy ≤ 2 weeks prior to registration.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00398710
Start Date
October 1 2006
End Date
October 1 2011
Last Update
March 15 2018
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115