Subcutaneous Amifostine Safety Study
Information source: Mt. Sinai Medical Center, Miami
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Lung Cancer; Lymphoma
Intervention: Amifostine administered subcutaneously (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mt. Sinai Medical Center, Miami Official(s) and/or principal investigator(s):
Michael A Samuels, MD, Principal Investigator, Affiliation: Mt. Sinai Medical Center
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.
Clinical Details
Official title: Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Study design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Primary outcome: Incidence of nausea/vomitingIncidence of hypotension Incidence of generalized skin rash Incidence of injection-site skin toxicity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mt. Sinai Medical Center, Miami Beach, Florida 33140, United States
Additional Information
Starting date: January 2002
Ending date: January 2005
Last updated: September 7, 2005
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