We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subcutaneous Amifostine Safety Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158041
First Posted: September 12, 2005
Last Update Posted: September 12, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MedImmune LLC
Information provided by:
Mt. Sinai Medical Center, Miami
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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


Locations
United States, Florida
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
MedImmune LLC
Investigators
Principal Investigator: Michael A Samuels, MD Mt. Sinai Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00158041     History of Changes
Other Study ID Numbers: ETH056-01D
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: September 12, 2005
Last Verified: September 2005

Keywords provided by Mt. Sinai Medical Center, Miami:
Amifostine
Mucositis
Nausea
Hypotension
Rash

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs