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Sponsors and Collaborators: |
Mt. Sinai Medical Center, Miami MedImmune LLC |
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Information provided by: | Mt. Sinai Medical Center, Miami |
ClinicalTrials.gov Identifier: | NCT00158041 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer Lung Cancer Lymphoma |
Drug: Amifostine administered subcutaneously |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Mt. Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 |
Principal Investigator: | Michael A Samuels, MD | Mt. Sinai Medical Center |
Study ID Numbers: | ETH056-01D |
Study First Received: | September 7, 2005 |
Last Updated: | September 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00158041 |
Health Authority: | United States: Institutional Review Board |
Amifostine Mucositis Nausea Hypotension Rash |
Hypotension Thoracic Neoplasms Immunoproliferative Disorders Amifostine Mucositis Exanthema Lymphatic Diseases |
Respiratory Tract Diseases Lung Neoplasms Head and Neck Neoplasms Lung Diseases Nausea Lymphoproliferative Disorders Lymphoma |
Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Immune System Diseases Physiological Effects of Drugs Protective Agents Pharmacologic Actions |