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

Phase 1

Completed

• Conditions: Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00962507
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	90 days post treatment start
Toxicity	90 days post treatment start

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic and correlative studies	Day 1 and Day 26 of the first cycle of treament

Trial Locations

Locations (2)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

City of Hope Medical Group; 🇺🇸 Pasadena, California, United States