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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: March 25, 2013
Last verified: April 2000

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.

Condition Intervention Phase
Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific Drug: amifostine trihydrate Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1997
Study Completion Date: September 2004
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically proven cancer No brain or other CNS metastases (including prior treated metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: No grade 3 or greater hepatic dysfunction Renal: No hypercalcemia Cardiovascular: No uncontrolled hypotension Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No psychosis No severe concurrent illness other than neoplasia No epileptic seizures during the previous year, migraines, gastrointestinal obstructions, or other causes of vomiting No prior or concurrent amifostine contraindications No prior known contraindications or sensitivity to dexamethasone, granisetron, ondansetron, prochlorperazine, diphenhydramine, cimetidine, or magnesium

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior estrogen within 24 hours of amifostine therapy Radiotherapy: Not specified Surgery: Not specified Other: No prior alcohol, disulphiram, tetracycline, or erythromycin within 24 hours of amifostine therapy No prior antiemetics such as benzodiazepines, antipsychotics, anticonvulsants, or antihistamines within 24 hours of amifostine therapy

  Contacts and Locations
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Please refer to this study by its identifier: NCT00003252

United States, Illinois
Rush North Shore Medical Center
Skokie, Illinois, United States, 60076
Sponsors and Collaborators
Rush North Shore Medical Center
Study Chair: Edward H. Kaplan, MD Rush North Shore Medical Center
  More Information Identifier: NCT00003252     History of Changes
Other Study ID Numbers: CDR0000066134
Study First Received: November 1, 1999
Last Updated: March 25, 2013

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
drug/agent toxicity by tissue/organ

Additional relevant MeSH terms:
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 19, 2017