Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Objectives:
Primary:
- 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
Secondary:
- Determine the in vivo effect of therapy on selected serum cytokines/chemokines
(TGF-beta, thymus and activation-regulated chemokine (TARC), IL-6, IL-10, VEGF).
- Examine pre-treatment level of selected molecular targets (HDACs 1-11, STAT6, pSTAT6,
STAT3, pSTAT3, Myc, Akt, Pichia anomala killer toxin (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.