Subcutaneous Amifostine Safety Study

Phase 4

Completed

• Conditions: Head and Neck Cancer; Lung Cancer; Lymphoma

• Registration Number: NCT00158041
• Lead Sponsor: Mt. Sinai Medical Center, Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study Completion: 2005-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Last Update Submitted: 2005-09-07
• Study First Posted: 2005-09-12
• Last Update Posted: 2005-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mt. Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States