Clinical Trials Directory

Trials / Completed

CompletedNCT00004241

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma

A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin

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

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer, malignant lymphoma, or sarcoma

Detailed description

PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma. II. Determine the significant toxic effects associated with this drug in these patients. III. Determine the response in patients treated with this drug. IV. Determine the pharmacokinetics of 17-AAG and 17AG in these patients. OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules. Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. In both schedules, cohorts of 3-6 patients receive escalating doses of 17-AAG 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. At least 6 patients receive treatment at the MTD. PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGtanespimycinGiven IV
OTHERpharmacological studyCorrelative studies

Timeline

Start date
1999-10-01
Primary completion
2006-05-01
First posted
2003-01-27
Last updated
2013-02-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004241. Inclusion in this directory is not an endorsement.