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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


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

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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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution

Principal Investigator

Michael J. Greenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Dale & Frances Hughes Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

Ethyol Study #ETH156-03D

NCT ID:

NCT00130143

Start Date:

June 2003

Completion Date:

September 2004

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

The Dale & Frances Hughes Cancer CenterEast Stroudsburg, Pennsylvania  18301