Subcutaneous Amifostine Safety Study

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Collaborator: MedImmune LLC
• Treatments: Amifostine

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