Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma
Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the novel combination of everolimus + Panobinostat (LBH589) in a phase-I study in patients with relapsed lymphoma (Hodgkin and non-Hodgkin).
Determine the safety and efficacy of this novel combination in a phase-II study in patients with relapsed Hodgkin and non-Hodgkin lymphoma
Determine the in vivo effect of therapy on selected serum cytokines/chemokines (TGF-beta, TARC, IL-6, IL-10, VEGF).
Examine pre-treatment level of selected molecular targets (HDACs 1-11, STAT6, pSTAT6, STAT3, pSTAT3, Myc, Akt, pAkt, S6, pS6, p21, cyclin D1) in primary lymphoma cells and the surrounding reactive inflammatory cells obtained by core needle biopsies from patients with relapsed lymphoma.
Examine the correlation between molecular and biologic markers and clinical response and/or treatment-related toxicity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II of Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma|
- Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) [ Time Frame: 28 day treatment cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Panobinostat + Everolimus
Panobinostat (LBH589) Plus Everolimus (RAD001)
Starting dose of 10 mg by mouth per day, self-administered (by patients), 3 x per week
Other Name: LBH589Drug: Everolimus
Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal.
Show Detailed Description
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Yasuhiro Oki, MD||M.D. Anderson Cancer Center|