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Amifostine for Head and Neck Irradiation in Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
MedImmune LLC
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136474
First received: August 25, 2005
Last updated: October 30, 2009
Last verified: October 2009
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Amifostine
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014