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RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.
I. To establish the maximum tolerated dose of RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase I) II. To assess tumor response to RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase II)
I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving RAD001 and lenalidomide.
II. To describe the adverse event profile (using CTCAE CTEP Active Version) of RAD001 and lenalidomide.
OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adult Nasal Type Extranodal NK/T-cell Lymphoma
everolimus, lenalidomide, laboratory biomarker analysis, polymorphism analysis, immunohistochemistry staining method, microarray analysis, fluorescence in situ hybridization
Mayo Clinic Scottsdale-Phoenix
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:15:41-0400
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