Lymphoma Clinical Trial
Official title:
Phase II Trial of Everolimus (RAD001) in Relapsed/Refractory Lymphoma
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying the side effects and how well everolimus works in
treating patients with lymphoma that has relapsed or not responded to previous treatment.
OBJECTIVES:
Primary
- Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin
lymphoma (closed to accrual as of 8/18/08), aggressive non-Hodgkin's lymphoma (closed to
accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular
lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of
9/2/08), including Hodgkin's lymphoma, treated with everolimus.
Secondary
- Evaluate overall survival, progression-free survival, and time to disease progression in
patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to histology
(aggressive lymphoma [closed to accrual as of 2/7/08 except for diffuse large B cell
lymphoma, grade III follicular lymphoma, or transformed lymphoma] vs indolent lymphoma
[closed to accrual as of 8/18/08] vs uncommon lymphoma [closed to accrual as of 9/2/08]).
Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients undergo blood and tissue collection at baseline and periodically during study
treatment for translational research studies. Blood and tissue samples are analyzed for
biomarkers to study the effect of everolimus on lymphoma.
After completion of study treatment, patients are followed periodically for up to 5 years.
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