Subcutaneous Amifostine Safety Study

Completed · Phase 4

Conditions studied: Head and Neck Cancer, Lung Cancer, Lymphoma

In brief

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.

Key facts

Study ID

NCT00158041

Run by

Mt. Sinai Medical Center, Miami

People needed

452

Starts

2002-01-01

Expected to finish

2005-01-01

Last updated by the study team

2005-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Mt. Sinai Medical Center — Miami Beach, Florida, United States

Full record on ClinicalTrials.gov

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