Clinical Trials Directory

Trials / Completed

CompletedNCT01567709

Alisertib in Combination With Vorinostat in Treating Patients With Relapsed or Recurrent Hodgkin Lymphoma, B-Cell Non-Hodgkin Lymphoma, or Peripheral T-Cell Lymphoma

Phase I Study of the Aurora Kinase a Inhibitor MLN8237 in Combination With the Histone Deacetylase Inhibitor Vorinostat in Lymphoid Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
34 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and the best dose of alisertib when given together with vorinostat in treating patients with Hodgkin lymphoma, B-cell non-Hodgkin lymphoma, or peripheral T-cell lymphoma that has come back. Alisertib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) of MLN8237 (alisertib) when given in combination with vorinostat and to select a dose and schedule for further testing (recommended Phase 2 dose: RP2D) in patients with lymphoid malignancies. II. To describe the toxicities of MLN8237 when given in combination with vorinostat on a 21-day schedule. III. To determine any clinical responses with MLN8237 in combination with vorinostat. IV. To compare the plasma pharmacokinetics of MLN8237 when given alone and in combination with vorinostat. V. To perform immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) analysis to determine aurora kinase A (AURKA) expression in archival formalin-fixed paraffin-embedded sections from the most recent available tumor specimens of patients. VI. To perform correlative studies for apoptosis and proliferation on bone marrow and lymph node specimens, where available, obtained from patients in the expanded cohort at RP2D. OUTLINE: This is a dose-escalation study of alisertib. Patients receive alisertib orally (PO) twice daily (BID) on days 1-7 or days 1-3 and 8-10, and vorinostat PO BID on days 1-14 or days 1-5 and 8-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days.

Conditions

Interventions

TypeNameDescription
DRUGAlisertibGiven PO
OTHERLaboratory Biomarker AnalysisCorrelative studies
OTHERPharmacological StudyCorrelative studies
DRUGVorinostatGiven PO

Timeline

Start date
2012-04-16
Primary completion
2018-03-29
Completion
2018-03-29
First posted
2012-03-30
Last updated
2018-04-11

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01567709. Inclusion in this directory is not an endorsement.