Status:
COMPLETED
Subcutaneous Amifostine Safety Study
Lead Sponsor:
Mt. Sinai Medical Center, Miami
Collaborating Sponsors:
MedImmune LLC
Conditions:
Head and Neck Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 admi...
Eligibility Criteria
Inclusion
- 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
- Allergy to amifostine
- Life expectancy less than 6 mos
- Investigational drug within last 4 weeks
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00158041
Start Date
January 1 2002
End Date
January 1 2005
Last Update
September 12 2005
Active Locations (1)
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1
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140