Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities - Full Text View

Sponsors and Collaborators:	The Dale & Frances Hughes Cancer Center MedImmune LLC
Information provided by:	The Dale & Frances Hughes Cancer Center
ClinicalTrials.gov Identifier:	NCT00130143

Purpose

Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.

Condition	Intervention
Head and Neck Cancer Lung Cancer	Drug: Ethyol (Amifostine)

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

Drug Information available for: Amifostine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Further study details as provided by The Dale & Frances Hughes Cancer Center:

Primary Outcome Measures:

Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities

Secondary Outcome Measures:

Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients

Estimated Enrollment:	20
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2004

Detailed Description:

The protective capacity of thio-containing compounds against normal tissue damage from radiation have been recognized for over 40 years..

Although intravenous administration is the approved standard route, because of practical advantages there has been increasing interest in the subcutaneous administration of Ethyol, which presents multiple advantages when used for radioprotection.

Based on the data that has been presented, as well as the personal experience of this and other physicians/centers with subcutaneous administration of amifostine, the researchers are proposing an open-label study evaluating the rate and severity of toxicities associated with this route of administration. Toxicities to be assessed include nausea/vomiting, hypotension, and skin/fever reactions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patient is eligible to receive subcutaneous amifostine under site’s current practice guidelines for radioprotection.
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Age > 18
Patient receiving radiation therapy or combined modality therapy to treat malignancy.
No evidence of distant metastatic disease.
Granulocyte count (segs & bands) > 2000/mm3 and platelet count > 100,000/mm3
Serum creatinine <2.0mg/dL
Total bilirubin <2.0mg%, SGOT < times the upper limit of normal.
Patients may not be entered on investigational therapeutic trials.
Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.

Exclusion Criteria:

Life expectancy of <6 months
Patients receiving only chemotherapy to treat malignancy.
Patients who have been treated with any investigational drugs <4 weeks prior to study entry.
General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130143

Locations

United States, Pennsylvania
The Dale & Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301

Sponsors and Collaborators

The Dale & Frances Hughes Cancer Center

MedImmune LLC

Investigators

Principal Investigator:

Michael J. Greenberg, M.D.

The Dale & Frances Hughes Cancer Center

More Information

Study ID Numbers:	Ethyol Study #ETH156-03D
Study First Received:	August 12, 2005
Last Updated:	September 26, 2005
ClinicalTrials.gov Identifier:	NCT00130143
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Thoracic Neoplasms
Amifostine
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Head and Neck Neoplasms

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Radiation-Protective Agents
Neoplasms
Neoplasms by Site

Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009