Amifostine for Head and Neck Irradiation in Lymphoma
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma; Hodgkin's Disease; Non-Hodgkin's Lymphoma
Intervention: Amifostine (Drug); Radiation Therapy (Radiation)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute
Official(s) and/or principal investigator(s):
Andrea K. Ng, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
The purpose of this study is determine the effects (good and bad) amifostine has on
radiation-induced side effects of lymphoma treatment.
Official title: A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
To determine the quality-of-life of patients receiving radiation therapy and amifostine
to determine the safety of amifostine
Patients will be randomized into one of two study groups. One study group will receive
amifostine prior to daily radiation therapy and the other group will receive radiation
Amifostine will be administered 30-60 minutes prior to radiation treatment. Vital signs will
be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately
following radiation treatment.
Patients will also complete a quality-of-life questionnaire on the first and last day of
radiation treatment. Follow-up questionnaires will be done at follow-up visits 1 month, 3
months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy.
Patients will be removed from the study if they develop an allergic reaction to amifostine.
Minimum age: 35 Years.
Maximum age: N/A.
- Patients must be 35 years or older
- Histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma receiving
radiation therapy to the head and neck area.
- Involvement of one or more of the following sites: cervical node, supraclavicular
node, pre-auricular node, submental node, any salivary glands, any parts of the oral
cavity, or any parts of the oropharynx.
- Prior history of head and neck malignancies
- Prior radiation therapy to the head and neck region
- Patients with stage I Hodgkin's disease receiving radiation therapy alone
- Pregnant or lactating women
- Myocardial infarction within the 6 months of enrollment
- Clinically evident pulmonary insufficiency, except for patients with exertional
dyspnea related to chest tumor itself.
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States
Starting date: May 2003
Ending date: May 2008
Last updated: December 27, 2007