Subcutaneous Amifostine Safety Study

This study has been completed.

First Received: September 7, 2005 No Changes Posted

Sponsor:	Mt. Sinai Medical Center, Miami
Collaborator:	MedImmune LLC
Information provided by:	Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:	NCT00158041

Purpose

Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Condition	Intervention	Phase
Head and Neck Cancer Lung Cancer Lymphoma	Drug: Amifostine administered subcutaneously	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:	Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Low Blood Pressure Lung Cancer Lymphoma Nausea and Vomiting Rashes

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:

Incidence of nausea/vomiting
Incidence of hypotension
Incidence of generalized skin rash
Incidence of injection-site skin toxicity

Estimated Enrollment:	452
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Institutional criteria for administration of amifostine
Radiation therapy
ECOG PS of at least 2
No distant mets
Granulocyte count greater than 2000
Platelet count greater than 100,000
Creatinine less than 2.0

Exclusion Criteria:

Allergy to amifostine
Life expectancy less than 6 mos
Investigational drug within last 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158041

Locations

United States, Florida
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140

Sponsors and Collaborators

Mt. Sinai Medical Center, Miami

MedImmune LLC

Investigators

Principal Investigator:

Michael A Samuels, MD

Mt. Sinai Medical Center

More Information

No publications provided

Study ID Numbers:	ETH056-01D
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00158041 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mt. Sinai Medical Center, Miami:

Amifostine
Mucositis
Nausea
Hypotension
Rash

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Radiation-Protective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Amifostine
Immune System Diseases
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

Lymphatic Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Head and Neck Neoplasms
Lung Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010