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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
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.
OBJECTIVES: Primary * 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. Secondary * 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope Medical Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Start Date
July 1, 2009
Primary Completion Date
January 1, 2013
Completion Date
January 1, 2013
Last Updated
February 15, 2013
11
ACTUAL participants
everolimus
DRUG
panobinostat
DRUG
laboratory biomarker analysis
OTHER
pharmacological study
OTHER
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT06263491
NCT06337318
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07388563