Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

This study is currently recruiting participants.
Verified May 2012 by Mayo Clinic

First Received on June 1, 2009.  
Last Updated on May 14, 2012  
History of Changes
This Clinical Trial Sponsored By: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00918333
 

Purpose for Clinical Trial

RATIONALE: Panobinostat and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of panobinostat and everolimus when given together and to see how well they work in treating patients with recurrent multiple myeloma, non-Hodgkin lymphoma, or Hodgkin lymphoma.

Condition Study Intervention Clinical Trial Phase
Hematopoietic/Lymphoid Cancer
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Primary Central Nervous System Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Multiple Myeloma
Splenic Marginal Zone Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
Waldenstrom Macroglobulinemia
Drug: panobinostat
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Other: flow cytometry
Other: immunohistochemistry staining method
Other: western blotting
Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Chronic Lymphocytic Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Drug Information available for:
Sirolimus
Everolimus
Temsirolimus

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures For Clinical Trial:

  • Toxicity, as assessed by NCI CTCAE v3.0 (phase I) [ Designated as safety issue: Yes ]
  • Proportion of confirmed tumor responses (i.e., CR, CRu, sCR, VGPR, or PR) (phase II) [ Time Frame: Using up to 12 cycles of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Survival time [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Pharmacologic (pharmacokinetic/pharmacodynamic) parameters and biological (correlative laboratory) results and correlation to differences between responders and non-responders [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: June 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Arm I

Patients receive oral panobinostat (Monday, Wednesday, Friday) and oral everolimus once daily.
Drug: panobinostat

Given orally
Other Names:
  • Faridak
  • HDAC inhibitor LBH589
  • histone deacetylase inhibitor LBH589
  • LBH589

Drug: everolimus

Given orally
Other Names:
  • 42-O-(2-hydroxy)ethyl rapamycin
  • Afinitor
  • RAD001

Other: laboratory biomarker analysis
Other: pharmacological study

Other Name: pharmacological studies

Other: flow cytometry
Other: immunohistochemistry staining method

Other Name: immunohistochemistry

Other: western blotting

Other Names:
  • Blotting, Western
  • Western Blot

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated doses (MTD) of LBH589 and RAD001 when used in combination in patients with myeloma or lymphoma (Phase I).

II. Arm A: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory lymphoma. (Phase II)

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