Clinical Trials Directory

Trials / Completed

CompletedNCT00089271

17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas

A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
60 (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 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or die

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors or lymphomas. II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. IV. Determine the recommended phase II dose of this drug for future studies. SECONDARY OBJECTIVES: I. Determine tumor response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of 17-DMAG 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 DLT. Patients are followed at 4 weeks.

Conditions

Interventions

TypeNameDescription
DRUGalvespimycin hydrochlorideGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-07-01
Primary completion
2010-06-01
First posted
2004-08-05
Last updated
2013-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00089271. Inclusion in this directory is not an endorsement.