Amifostine for Head and Neck Irradiation in Lymphoma - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Brigham and Women's Hospital Beth Israel Deaconess Medical Center MedImmune LLC
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00136474

Purpose

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

Condition	Intervention	Phase
Lymphoma Hodgkin's Disease Non-Hodgkin's Lymphoma	Drug: Amifostine Radiation: Radiation Therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the quality-of-life of patients receiving radiation therapy and amifostine [ Time Frame: TBD ] [ Designated as safety issue: No ]
to determine the safety of amifostine [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	May 2003
Study Completion Date:	March 2009
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136474

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
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

No publications provided

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
Study First Received:	August 25, 2005
Last Updated:	October 30, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Lymphoma
Radiation therapy
Amifostine

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012