Date: 8/31/2006
Sponsor: Novartis, Inc.
Institution: Mayo Clinic
Physician: Irene Ghobrial, MD; Dana-Farber Cancer Institute

This clinical trial will evaluate a drug called RAD001 as a possible treatment for relapsed/refractory WM. The purpose of this study is to find out what effects the drug has on patients and their lymphoma, and learn about the effects of the drug on blood cells from patients with lymphoma who receive it. RAD001 is an antiproliferative drug with applications as an immunosuppressant and anticancer agent. This drug has been used in the solid organ transplantation setting and information from those other research studies suggests that this agent may help to produce antitumor responses in patients with relapsed/refractory lymphoma. We will assess tumor response to RAD001 and evaluate toxicity associated with this therapy in eligible patients.

Patients eligible for this study who choose to participate will receive up to 12 cycles of treatment, each 4 weeks long. Subjects will take RAD001 every day by mouth. After the third cycle, subjects will be assessed. If there are severe side effects or if the disease has progressed, the subject will be taken off the study. Otherwise, the subject will continue through three more cycles and be assessed again. If there are no serious side effect and the disease does not progress, the subject will go through 6 more cycles. After the 12th week, subjects will return for follow up evaluation every 3 months in the first year, every 4 months in the second year, every 6 months in the third year and every 12 months thereafter.