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Subcutaneous Amifostine Safety Study

This study has been completed.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by:
Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00158041
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
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:

Drug Information available for: Amifostine
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Amifostine
Mucositis
Nausea
Hypotension
Rash

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Lymphoma
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013