Phase II Study of Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : RAD001
Phase: Phase 2
Ages Eligible For Study:
- 18 years of age or older - Adequate liver and renal function as outlined in the protocol - Fasting serum cholesterol 300mg/dl or less OR 7.75mmol/L or less AND fasting triglycerides 2.5 x institutional ULN or less. - Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by consensus panel of the Second International Workshop on Waldenstrom's macroglobulinemia - No previous therapy for WM - 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 or greater is required - ECOG Performance status of 0-2 - Patients must have a life expectancy of at least 3 months - Baseline platelet and absolute neutrophil as outlined in the protocol - INR and PTT 1.5 x normalized ratio or less - A male subject agrees to use an acceptable method for contraception for the duration of study and for 8 weeks after the last dose of the study drug - Female subject either post-menopausal or surgically sterilized or willing to use acceptable methods of birth control for the duration of the study and for 8 weeks after the last dose of study drug