Head and Neck CancerPhase 2NCT00409331
Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
A Phase 2 study testing Amifostine and Intensity- Modulated Radiation Therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Amifostine and Intensity- Modulated Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women of at least 18 years of age at the time of patient entry;
- Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum pregnancy test within 7 days of study entry;
- Men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the informed consent is signed, and must agree to continue using such precautions while receiving IMRT through 6 weeks after the last dose of amifostine or RT, whichever is the last therapy discontinued;
- Patients undergoing definitive or post-operative IMRT as follows:
- Definitive Patients: Histology confirmed unknown primary T0N1-2bM0 or oropharynx Stage I, II, III, IV (TX, T1-T2, favorable T3 (exophytic) N0-N2b, M0), small volume primary and nodal, not requiring chemotherapy during RT (i.e., induction chemo is acceptable as well as concurrent biological therapy e.g., Cetuximab), squamous cell carcinoma (AJCC Staging of HNSCC). Lymph nodes bilaterally of the neck are at risk for metastatic disease and require irradiation per clinical judgment.
- Post-operative Patients: Histology confirmed oral cavity, oropharynx, larynx and hypopharynx squamous cell carcinoma (AJCC Staging of HNSCC): *Stage III and IV squamous cell carcinoma treated with surgery as the primary modality requiring post-operative RT, but not receiving concurrent chemotherapy. *Indications for post-operative RT include: unfavorable T3 and T4 primaries, compromised margins, nodal metastases, extracapsular nodal extension, perineural invasion and lymphovascular invasion.
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- Zubrod performance status of 0 or 1
- Adequate nutritional status as determined by the treating physician in conjunction with consultation with clinical nutritionists, as indicated.
- Hemoglobin must be greater than or equal to 10 g/dL.
- At least one parotid should keep a mean RT dose of < 24-26 Gy. If this cannot be achieved on one side, then the contralateral parotid dosing goal is to keep the mean dose as low as possible, typically <15 Gy.
- It is anticipated that at least one submandibular gland will receive a mean dose >24-26 Gy.
- Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Evidence of significant wound infection, fistula, or major wound dehiscence at time of patient entry.
- Carcinomas of the paranasal sinuses, nasopharynx, or N3 at time of patient entry.
- Presence of prior malignancies <5 years other than non-melanoma skin cancer or cervical, breast or bladder cancer in situ.
- T3N0 glottic cancer at time of patient entry.
- Prior chemotherapy for other cancer within less than or equal to 3 years prior to patient entry.
- Planned concurrent or adjuvant chemotherapy.
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- Less than gross total resection for patients on post-operative RT.
- Prior head neck irradiation except for localized non-melanomatous cutaneous carcinomas.
- Salivary gland disease, e.g. Sjogren's disease at time of patient entry.
- Pregnant or nursing at the time of patient entry or positive serum pregnancy test within 7 days of study entry.
- Use of pilocarpine or cevimeline during participation in the study.
- General medical or psychological conditions that might preclude the patient from completion of the study or from understanding and signing the informed consent.
- Evidence of distant metastases.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing
Primary Objective:
To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
Read more
Secondary Objectives:
- To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
- To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
- To observe the incidence and patterns of occipital scalp epilation;
- To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
- To further evaluate the safety profile of amifostine in this patient population.
Read the detailed description
Amifostine is designed to protect the cells in normal tissues against the toxicities of chemotherapy and radiation therapy.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.
Blood (about 2 tablespoons) will be drawn for routine blood tests. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), weight, and height. You will have a dental exam. You will complete a questionnaire that asks questions about dry mouth. In addition, you will be asked questions about your diet and eating habits. This should take no longer than 10 minutes. Also, saliva will be collected by a simple, in-office oral test that measures saliva flow rate over a 5 minute period. Women who are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive IMRT Monday -Friday over a 6-7 week period. In addition, 2-3 hours before IMRT, you will also take pre-medications by mouth to prevent potential nausea and skin reactions (anti-nausea \& antihistamine), including drinking water.You will receive daily IMRT therapy, excluding weekends and holidays. The radiation dose is designed to conform to the 3-dimensional shape of the tumor by controlling the intensity of the radiation beam to focus a higher radiation dose on the tumor (and not the surrounding normal tissue). Thirty (30) to 60 minutes before every IMRT treatment, you will receive study drug in two injections beneath the skin. IMRT will take about 30 minutes to complete.
Every day that you are receiving IMRT (Monday-Friday), you will be asked about any drugs you are taking and any side effects you are experiencing. Your vital signs will be recorded.
Every week (Weeks 2-7), you will have a complete oral and physical exam. You will complete the questionnaire that asks questions about dry mouth. You will be asked questions about your ability to perform daily activities (performance status evaluation). Your weight will also be measured. You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities.
On the last day you receive IMRT or amifostine (whichever is last), you will have a complete oral exam and you will complete the questionnaire about dry mouth.
Six (6) weeks after the end of therapy, you will have an end-of-therapy visit. At this visit, you will have a complete physical and oral exam with a saliva collection. You will complete the questionnaire about dry mouth. Your weight will be measured, and you will have a performance status evaluation. Blood (about (2) tablespoons) will be drawn for routine blood tests. You will be asked about any drugs you are taking and any side effects you are experiencing. In addition, you will be asked questions about your diet and eating habits.
You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities every week for 2 months after the end of radiation therapy. After this point, you will be asked to complete the symptom survey every month for 1 year.
You will have follow-up visits 4, 7, 10, and 12 months after the end of therapy. At these visits, you will have a complete oral exam and saliva collection. You will complete the dry mouth questionnaire. Your weight will be measured, and you will have a performance status evaluation and you will be asked questions about your diet and eating habits.
THIS IS AN INVESTIGATIONAL STUDY. Amifostine is FDA approved and commercially available. Amifostine is FDA approved to be given through a needle in your vein but not FDA approved to be given through a needle under the skin.
Up to 20 patients will take part in this study. All patients will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Amifostine, Intensity- Modulated Radiation Therapy
- Keywords
- Head and Neck Cancer, HNSCC, Submandibular and Sublingual Salivary Sparing, Amifostine, Ethyol, Radiation Therapy
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
Also called Ethyol
500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
Intensity- Modulated Radiation TherapyProcedure or surgery
Also called IMRT
2.0 to 2.2 Gy delivered in 30 fractions
| Study group | Role | What they receive |
|---|---|---|
| IMRT + Amifostine | Experimental | Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT. Receives: Drug: Amifostine; Procedure: Intensity- Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Clinically Relevant Salivary Flow (CRSF)
Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Study terminated by Principal Investigator; no patients completed study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Mark Chambers, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409331
- Sponsor's protocol ID
- 2006-0234
- Status last verified
- Jul 2012
- First submitted
- 7 Dec 2006
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing
- ClinicalTrials.gov ID
- NCT00409331
- Acronym / sponsor ID
- 2006-0234
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, HNSCC, Submandibular and Sublingual Salivary Sparing, Amifostine, Ethyol, Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by Principal Investigator; no patients completed study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
Secondary Objectives:
- To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
- To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
- To observe the incidence and patterns of occipital scalp epilation;
- To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
- To further evaluate the safety profile of amifostine in this patient population.
Detailed description
Amifostine is designed to protect the cells in normal tissues against the toxicities of chemotherapy and radiation therapy.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.
Blood (about 2 tablespoons) will be drawn for routine blood tests. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), weight, and height. You will have a dental exam. You will complete a questionnaire that asks questions about dry mouth. In addition, you will be asked questions about your diet and eating habits. This should take no longer than 10 minutes. Also, saliva will be collected by a simple, in-office oral test that measures saliva flow rate over a 5 minute period. Women who are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive IMRT Monday -Friday over a 6-7 week period. In addition, 2-3 hours before IMRT, you will also take pre-medications by mouth to prevent potential nausea and skin reactions (anti-nausea \& antihistamine), including drinking water.You will receive daily IMRT therapy, excluding weekends and holidays. The radiation dose is designed to conform to the 3-dimensional shape of the tumor by controlling the intensity of the radiation beam to focus a higher radiation dose on the tumor (and not the surrounding normal tissue). Thirty (30) to 60 minutes before every IMRT treatment, you will receive study drug in two injections beneath the skin. IMRT will take about 30 minutes to complete.
Every day that you are receiving IMRT (Monday-Friday), you will be asked about any drugs you are taking and any side effects you are experiencing. Your vital signs will be recorded.
Every week (Weeks 2-7), you will have a complete oral and physical exam. You will complete the questionnaire that asks questions about dry mouth. You will be asked questions about your ability to perform daily activities (performance status evaluation). Your weight will also be measured. You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities.
On the last day you receive IMRT or amifostine (whichever is last), you will have a complete oral exam and you will complete the questionnaire about dry mouth.
Six (6) weeks after the end of therapy, you will have an end-of-therapy visit. At this visit, you will have a complete physical and oral exam with a saliva collection. You will complete the questionnaire about dry mouth. Your weight will be measured, and you will have a performance status evaluation. Blood (about (2) tablespoons) will be drawn for routine blood tests. You will be asked about any drugs you are taking and any side effects you are experiencing. In addition, you will be asked questions about your diet and eating habits.
You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities every week for 2 months after the end of radiation therapy. After this point, you will be asked to complete the symptom survey every month for 1 year.
You will have follow-up visits 4, 7, 10, and 12 months after the end of therapy. At these visits, you will have a complete oral exam and saliva collection. You will complete the dry mouth questionnaire. Your weight will be measured, and you will have a performance status evaluation and you will be asked questions about your diet and eating habits.
THIS IS AN INVESTIGATIONAL STUDY. Amifostine is FDA approved and commercially available. Amifostine is FDA approved to be given through a needle in your vein but not FDA approved to be given through a needle under the skin.
Up to 20 patients will take part in this study. All patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT + Amifostine | Experimental | Drug: Amifostine, Procedure: Intensity- Modulated Radiation TherapyIntensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult men and women of at least 18 years of age at the time of patient entry;
- Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum pregnancy test within 7 days of study entry;
- Men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the informed consent is signed, and must agree to continue using such precautions while receiving IMRT through 6 weeks after the last dose of amifostine or RT, whichever is the last therapy discontinued;
- Patients undergoing definitive or post-operative IMRT as follows:
- Definitive Patients: Histology confirmed unknown primary T0N1-2bM0 or oropharynx Stage I, II, III, IV (TX, T1-T2, favorable T3 (exophytic) N0-N2b, M0), small volume primary and nodal, not requiring chemotherapy during RT (i.e., induction chemo is acceptable as well as concurrent biological therapy e.g., Cetuximab), squamous cell carcinoma (AJCC Staging of HNSCC). Lymph nodes bilaterally of the neck are at risk for metastatic disease and require irradiation per clinical judgment.
Key exclusion criteria (13 listed)
- Evidence of significant wound infection, fistula, or major wound dehiscence at time of patient entry.
- Carcinomas of the paranasal sinuses, nasopharynx, or N3 at time of patient entry.
- Presence of prior malignancies <5 years other than non-melanoma skin cancer or cervical, breast or bladder cancer in situ.
- T3N0 glottic cancer at time of patient entry.
- Prior chemotherapy for other cancer within less than or equal to 3 years prior to patient entry.
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 |
|---|---|---|
| AmifostineAlso: Ethyol500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT. | Drug | IMRT + Amifostine |
| Intensity- Modulated Radiation TherapyAlso: IMRT2.0 to 2.2 Gy delivered in 30 fractions | Procedure or surgery | IMRT + Amifostine |
Primary outcome
12-month Clinically Relevant Salivary Flow (CRSF)
Time frame: 12 months
Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Mark Chambers, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 Intensity- Modulated Radiation Therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
12-month Clinically Relevant Salivary Flow (CRSF) (time frame: 12 months). 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 7 Aug 2012.