Subcutaneous Amifostine Safety Study

Mt. Sinai Medical Center, Miami

Status and phase: Completed; Phase 4

Conditions: Lung Cancer; Lymphoma; Head and Neck Cancer

Treatments: Drug: Amifostine administered subcutaneously

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00158041

ETH056-01D

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)