Clinical Trials Directory

Trials / Completed

CompletedNCT00348985

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

A Phase 1 Study of PXD101 in Combination With Bortezomib (PS-341) in Patients With Advanced Solid Tumors and Lymphoma

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

Summary

This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving PXD101 together with bortezomib may kill more cancer cells.

Detailed description

OBJECTIVES: I. Evaluate the safety profile and determine the maximum tolerated dose of PXD101 in combination with bortezomib in patients with advanced solid tumors or lymphomas. II. Determine the pharmacokinetics of the combination of PXD101 and bortezomib in these patients. III. Evaluate selected biomarkers of drug effect in these patients. IV. Evaluate the activity of this regimen, in terms of objective response rate, in these patients. OUTLINE: This is a dose-escalation study. Patients receive PXD101 IV over 30 minutes on days 1-5 and bortezomib IV on days 1, 4, 8, and 11 (2, 5, 8, and 11 during course 1). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-9 patients receive escalating doses of bortezomib and PXD101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Blood is collected at baseline and periodically during course 1 of study treatment for pharmacokinetic studies. After completion of study treatment, patients are followed periodically for 4 weeks.

Conditions

Interventions

TypeNameDescription
DRUGbelinostat
DRUGbortezomib
OTHERpharmacological study

Timeline

Start date
2006-03-01
Primary completion
2010-01-01
First posted
2006-07-06
Last updated
2013-05-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00348985. Inclusion in this directory is not an endorsement.