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Subcutaneous Amifostine Safety Study

This study has been completed.
MedImmune LLC
Information provided by:
Mt. Sinai Medical Center, Miami Identifier:
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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
Head and Neck Cancer Lung Cancer Lymphoma Drug: Amifostine administered subcutaneously Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Resource links provided by NLM:

Further study details as provided by Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:
  • Incidence of nausea/vomiting
  • Incidence of hypotension
  • Incidence of generalized skin rash
  • Incidence of injection-site skin toxicity

Estimated Enrollment: 452
Study Start Date: January 2002
Estimated Study Completion Date: January 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00158041

United States, Florida
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
MedImmune LLC
Principal Investigator: Michael A Samuels, MD Mt. Sinai Medical Center
  More Information Identifier: NCT00158041     History of Changes
Other Study ID Numbers: ETH056-01D
Study First Received: September 7, 2005
Last Updated: September 7, 2005

Keywords provided by Mt. Sinai Medical Center, Miami:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 18, 2017