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Amifostine for Head and Neck Irradiation in Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00136474
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : November 2, 2009
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Lymphoma Hodgkin's Disease Non-Hodgkin's Lymphoma Drug: Amifostine Radiation: Radiation Therapy Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Study Start Date : May 2003
Primary Completion Date : May 2005
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group 1
Amifostine plus radiation therapy
Drug: Amifostine
Given 30-60 minutes prior to daily radiation therapy
Radiation: Radiation Therapy
Daily radiation therapy
Active Comparator: Group 2
Radiation therapy alone
Radiation: Radiation Therapy
Daily radiation therapy


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the quality-of-life of patients receiving radiation therapy and amifostine
  2. to determine the safety of amifostine [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136474


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
MedImmune LLC
Investigators
Principal Investigator: Andrea K. Ng, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Andrea K. Ng, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00136474     History of Changes
Other Study ID Numbers: 02-292
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Dana-Farber Cancer Institute:
Lymphoma
Radiation therapy
Amifostine

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs