Status:
COMPLETED
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Lead Sponsor:
The Dale & Frances Hughes Cancer Center
Collaborating Sponsors:
MedImmune LLC
Conditions:
Head and Neck Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatme...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00130143
Start Date
June 1 2003
End Date
September 1 2004
Last Update
September 27 2005
Active Locations (1)
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1
The Dale & Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301