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Sponsors and Collaborators: |
AOI Pharma, Inc. Dana-Farber Cancer Institute |
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Information provided by: | AOI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00398710 |
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.
Condition | Intervention | Phase |
---|---|---|
Waldenström's Macroglobulinemia |
Drug: Perifosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia |
Estimated Enrollment: | 37 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | Irene M Ghobrial, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | Perifosine 221 |
Study First Received: | November 9, 2006 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00398710 |
Health Authority: | United States: Food and Drug Administration |
Waldenström's Macroglobulinemia Perifosine |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Lymphatic Diseases Waldenstrom Macroglobulinemia Hemorrhagic Disorders Waldenstrom macroglobulinemia Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |