Amifostine for Head and Neck Irradiation in Lymphoma

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

Secondary outcome:

To determine the quality-of-life of patients receiving radiation therapy and amifostine

to determine the safety of amifostine

Detailed description: 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 therapy alone.

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

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