NCT00003252

Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy

A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Rush North Shore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy.

Detailed description

OBJECTIVES: I. Determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy. OUTLINE: This is an open label, controlled study. Patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy. Patients are followed for one month post treatment. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

• Drug/Agent Toxicity by Tissue/Organ
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	amifostine trihydrate

Timeline

• Start date: 1997-12-01
• Completion: 2004-09-01
• First posted: 2004-09-10
• Last updated: 2013-03-26

Locations

1 site across 1 country: United States