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Completed

NCT Number: NCT00158041

Subcutaneous Amifostine Safety Study

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.

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Key information

Conditions

Head and Neck Cancer Cardiovascular Diseases Digestive System Diseases Exanthema Gastroenteritis Gastrointestinal Diseases Head and Neck Neoplasms Hemic and Lymphatic Diseases Hypotension Immune System Diseases Immunoproliferative Disorders Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Mouth Diseases Mucositis Nausea Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Thoracic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amifostine administered subcutaneously

Drug

Primary outcomes

  1. Incidence of nausea/vomiting

  2. Incidence of hypotension

  3. Incidence of generalized skin rash

  4. Incidence of injection-site skin toxicity

Sponsors and collaborators

Lead sponsor

Mt. Sinai Medical Center, Miami

Other

Collaborators

  • MedImmune LLC

Registry information

Official study title

Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Important dates

Study start
2002
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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