Clinical Trials Directory

Trials / Terminated

TerminatedNCT00096005

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

A Phase I Trial Of 17-Allylaminogeldanamycin (17-AAG) And PS341 In Advanced Malignancies

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

Summary

This phase I trial is studying the side effects and best dose of giving tanespimycin together with bortezomib in treating patients with advanced solid tumors or lymphomas. (Accrual for lymphoma patients closed as of 11/27/09) Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of tanespimycin by making cancer cells more sensitive to the drug. Combining tanespimycin with bortezomib may kill more cancer cells.

Detailed description

OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin) and bortezomib in patients with advanced solid tumors or lymphomas (Accrual for Lymphoma Patients Closed as of 11/27/09). II. Determine changes in biomarkers (e.g., HSP70, client proteins, and ubiquitination of proteins) in peripheral blood mononuclear cells and tumor specimens from patients with advanced solid tumors or lymphomas (Accrual for Lymphoma Patients Closed as of 11/27/09) treated with this regimen. III. Determine responses in patients treated with this regimen. IV. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive tanespimycin intravenously (IV) over 1-2 hours and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tanespimycin and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 12 additional patients are treated as above\* at the MTD. NOTE: \*Bortezomib is not administered on day 1 of course 1 only. Patients are followed at 3 months.

Conditions

Interventions

TypeNameDescription
DRUGtanespimycinGiven IV
DRUGbortezomibGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-11-01
Primary completion
2010-03-01
First posted
2004-11-09
Last updated
2014-02-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00096005. Inclusion in this directory is not an endorsement.