Panobinostat and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00962507|
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : February 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Drug: everolimus Drug: panobinostat Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
- Maximum tolerated dose [ Time Frame: 90 days post treatment start ]
- Toxicity [ Time Frame: 90 days post treatment start ]
- Pharmacokinetic and correlative studies [ Time Frame: Day 1 and Day 26 of the first cycle of treament ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|