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Subcutaneous Amifostine Safety Study

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ClinicalTrials.gov Identifier: NCT00158041
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
MedImmune LLC
Information provided by:
Mt. Sinai Medical Center, Miami

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 administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lung Cancer Lymphoma Drug: Amifostine administered subcutaneously Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
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
Study Start Date : January 2002
Estimated Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of nausea/vomiting
  2. Incidence of hypotension
  3. Incidence of generalized skin rash
  4. Incidence of injection-site skin toxicity

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00158041     History of Changes
Other Study ID Numbers: ETH056-01D
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 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