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Amifostine for Head and Neck Irradiation in Lymphoma

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amifostine
Radiation Therapy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, Radiation therapy, Amifostine

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Amifostine plus radiation therapy

Radiation therapy alone

Outcomes

Primary Outcome Measures

To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2005
Last Updated
October 30, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00136474
Brief Title
Amifostine for Head and Neck Irradiation in Lymphoma
Official Title
A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
Keywords
Lymphoma, Radiation therapy, Amifostine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Amifostine plus radiation therapy
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Radiation therapy alone
Intervention Type
Drug
Intervention Name(s)
Amifostine
Intervention Description
Given 30-60 minutes prior to daily radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Daily radiation therapy
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the quality-of-life of patients receiving radiation therapy and amifostine
Title
to determine the safety of amifostine
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea K. Ng, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Amifostine for Head and Neck Irradiation in Lymphoma

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