Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma
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.
- Determine the toxicity of this drug in these patients.
Secondary
- 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.
Interventional
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response, defined as complete response (CR), CR unconfirmed, or partial response (PR)
5 years
No
Thomas E. Witzig, MD
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000529824
NCT00436618
August 2005
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |