Amifostine for Head and Neck Irradiation in Lymphoma
This study has been completed.
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
First received: August 25, 2005
Last updated: October 30, 2009
Last verified: October 2009
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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
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 May 21, 2013