Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
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.
Brain and Central Nervous System Tumors
Small Intestine Cancer
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma|
- Confirmed response, defined as complete response (CR), CR unconfirmed, or partial response (PR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Duration of response (CR or PR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Correlation of molecular effects of everolimus on proteins downstream of MTOR, such as phospho-S6 and cyclin D1, with response to therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
- Determine the toxicity of this drug in these patients.
- Evaluate overall survival, progression-free survival, and time to disease progression in patients treated with this drug.
- Correlate known and unknown molecular markers with response 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 for up to 12 courses 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.
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Thomas E. Witzig, MD||Mayo Clinic|