Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Combination With mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Multiple Myeloma or Lymphoma
This phase I/II trial studies the side effects and best dose of panobinostat and everolimus when given together and to see how well they work in treating patients with multiple myeloma, non-Hodgkin lymphoma, or Hodgkin lymphoma that has come back. Panobinostat and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated doses (MTD) of LBH589 (panobinostat) and RAD001
(everolimus) when used in combination in patients with myeloma or lymphoma. (Phase I) II. To
evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with
relapsed or refractory lymphoma. (Arm A, phase II) III. To evaluate the therapeutic activity
of the combination of LBH589 with RAD001 in patients with relapsed or refractory multiple
myeloma. (Arm B, phase II)
SECONDARY OBJECTIVES:
I. To describe the toxicities associated with the combination of LBH589 with RAD001. (Phase
I) II. To further describe the toxicities associated with the combination of LBH589 with
RAD001 in each arm independently. (Phase II) III. To evaluate overall survival,
progression-free survival, and duration of response in each arm independently. (Phase II)
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetic interaction of LBH589 and RAD001. II. To assess the
correlation between clinical (toxicity and/or tumor response or activity) effects with the
pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative
laboratory) results.
OUTLINE: This is a phase I, dose-escalation study of panobinostat and everolimus followed by
a phase II study. (dose-escalation closed to accrual as of April 6, 2011)
Patients receive panobinostat orally (PO) once daily (QD) or on days 1, 3, 5, 15, 17, and 19
and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
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