NCT00962507

Panobinostat and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	everolimus	Beginning with 5 mg every other day Monday, Wednesday or Friday for a 28 day cycle. Dose escalation will be determined by the toxicities associated with treatment.
DRUG	panobinostat	10 mg every Monday and Thursday of a 28 day cycle. Dose escalation will be determined by the toxicities associated with treatment.
OTHER	laboratory biomarker analysis	Pre-study, day 1 and day 26 samples to evaluation how the study drugs work in vitro (in a test tube).
OTHER	pharmacological study	Pre-study, day 1 and day 26

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-08-20
• Last updated: 2013-02-15

Locations

2 sites across 1 country: United States