Subcutaneous Amifostine Safety Study

Lung Cancer Clinical Trial

Official title:

Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158041
• Other study ID #: ETH056-01D
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: September 2005
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lymphoma

Intervention

Drug:
• Amifostine administered subcutaneously

Locations

Country	Name	City	State
United States	Mt. Sinai Medical Center	Miami Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami	MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nausea/vomiting
Primary	Incidence of hypotension
Primary	Incidence of generalized skin rash
Primary	Incidence of injection-site skin toxicity