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


Phase 4
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Lung Cancer, Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of nausea/vomiting

Principal Investigator

Michael A Samuels, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mt. Sinai Medical Center

Authority:

United States: Institutional Review Board

Study ID:

ETH056-01D

NCT ID:

NCT00158041

Start Date:

January 2002

Completion Date:

January 2005

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • Lymphoma
  • Amifostine
  • Mucositis
  • Nausea
  • Hypotension
  • Rash
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Lymphoma

Name

Location

Mt. Sinai Medical CenterMiami Beach, Florida  33140