Back to resultsToxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Primary Purpose
Head and Neck Cancer, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethyol (Amifostine)
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility 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.
Sites / Locations
- The Dale & Frances Hughes Cancer Center
Outcomes
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
Full Information
NCT ID
NCT00130143
First Posted
August 12, 2005
Last Updated
September 26, 2005
Sponsor
The Dale & Frances Hughes Cancer Center
Collaborators
MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT00130143
Brief Title
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Official Title
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Dale & Frances Hughes Cancer Center
Collaborators
MedImmune LLC
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ethyol (Amifostine)
Primary Outcome Measure Information:
Title
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
Title
To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
Secondary Outcome Measure Information:
Title
Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Greenberg, M.D.
Organizational Affiliation
The Dale & Frances Hughes Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Dale & Frances Hughes Cancer Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
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