Panobinostat and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
RATIONALE: Panobinostat and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving panobinostat together with everolimus may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with everolimus in treating patients with relapsed or refractory lymphoma or multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Evaluating the Combination of the Deacetylase Inhibitor, LBH589 Plus the mTOR Inhibitor RAD001, in Relapsed and Refractory Adult Patients With Lymphoma|
- Maximum tolerated dose [ Time Frame: 90 days post treatment start ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: 90 days post treatment start ] [ Designated as safety issue: Yes ]
- Pharmacokinetic and correlative studies [ Time Frame: Day 1 and Day 26 of the first cycle of treament ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- To evaluate the safety and feasibility of combining panobinostat with everolimus in patients with recurrent or refractory lymphoma or multiple myeloma.
- To define the maximum tolerated dose of panobinostat in combination with everolimus in these patients.
- To obtain preliminary data for response to this treatment regimen in these patients.
- To perform correlative studies relevant to this treatment regimen.
OUTLINE: This is a dose-escalation study of panobinostat.
Patients receive oral panobinostat 3 days a week and oral everolimus once every other day for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples may be collected for pharmacokinetic and correlative laboratory studies.
After completion of study treatment, patients are followed up for ≥ 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962507
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Leslie Popplewell, MD||City of Hope Medical Center|