LymphomaPhase 2NCT00136474
Amifostine for Head and Neck Irradiation in Lymphoma
A Phase 2 study testing Amifostine and Radiation Therapy in people with Lymphoma and Hodgkin's Disease, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- What is being tested?
- Amifostine and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2003to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.
Read the 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.
- Conditions
- Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Being tested
- Amifostine, Radiation Therapy
- Keywords
- Lymphoma, Radiation therapy, Amifostine
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
Given 30-60 minutes prior to daily radiation therapy
Radiation TherapyRadiation
Daily radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Amifostine plus radiation therapy Receives: Drug: Amifostine; Radiation: Radiation Therapy |
| Group 2 | Active comparator | Radiation therapy alone Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
Measured: 2 years
Secondary outcomes (2)
To determine the quality-of-life of patients receiving radiation therapy and amifostine
to determine the safety of amifostine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMay 2003
- Primary completionMay 2005
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, MedImmune LLC
- Investigators
- Andrea K. Ng, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136474
- Sponsor's protocol ID
- 02-292
- Status last verified
- Oct 2009
- First submitted
- 25 Aug 2005
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
- ClinicalTrials.gov ID
- NCT00136474
- Acronym / sponsor ID
- 02-292
- Conditions
- Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
- Keywords
- Lymphoma, Radiation therapy, Amifostine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, MedImmune LLC
- Study start
- May 2003
- Primary completion
- May 2005 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Amifostine, Radiation: Radiation TherapyAmifostine plus radiation therapy |
| Group 2 | Active comparator | Radiation: Radiation TherapyRadiation therapy alone |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmifostineGiven 30-60 minutes prior to daily radiation therapy | Drug | Group 1 |
| Radiation TherapyDaily radiation therapy | Radiation | Group 1, Group 2 |
Primary outcome
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
Time frame: 2 years
2 secondary outcomes
To determine the quality-of-life of patients receiving radiation therapy and amifostine
to determine the safety of amifostine
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea K. Ng, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amifostine and Radiation Therapy in people with Lymphoma and Hodgkin's Disease, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2009.