Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy
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.
|Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific||Drug: amifostine trihydrate||Phase 4|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy|
|Study Start Date:||December 1997|
|Study Completion Date:||September 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003252
|United States, Illinois|
|Rush North Shore Medical Center|
|Skokie, Illinois, United States, 60076|
|Study Chair:||Edward H. Kaplan, MD||Rush North Shore Medical Center|