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
Drug: Amifostine administered subcutaneously
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided Identifier: NCT00158041     History of Changes
Other Study ID Numbers: ETH056-01D
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Mt. Sinai Medical Center, Miami:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents processed this record on October 09, 2015