Amifostine for Head and Neck Irradiation in Lymphoma

Lymphoma Clinical Trial

Official title:

A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136474
• Other study ID #: 02-292
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: October 30, 2009
• Start date: May 2003
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2009
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Amifostine
Given 30-60 minutes prior to daily radiation therapy

Radiation:
• Radiation Therapy
Daily radiation therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects		2 years	No
Secondary	To determine the quality-of-life of patients receiving radiation therapy and amifostine		TBD	No
Secondary	to determine the safety of amifostine		2 years	Yes